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Visual, Pregnancy Hcg, Prescription Use

Open-data reference.

FDA MAUDE adverse event data · 1996–2026

What the Data Shows About Visual, Pregnancy Hcg, Prescription Use

The FDA MAUDE database aggregates 3,737 adverse-event reports for Visual, Pregnancy Hcg, Prescription Use spanning the period from 1996 through 2026. Of these, 1 is classified as a death report, 197 as injury reports, and 3,209 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 10 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with False Positive Result topping the list at 1,210 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 31 years of MAUDE data, with the peak single-year volume reaching 571 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 13 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

3,737
Total Reports
1
Death Reports
197
Injury Reports
3,209
Malfunctions

Event Types

Malfunction 3,209 (85.9%)
Other 315 (8.4%)
Injury 197 (5.3%)
15 (0.4%)
Death 1 (0.0%)

Patient Outcomes

3,352 (88.9%)
Other 309 (8.2%)
Hospitalization 34 (0.9%)
Life Threatening 20 (0.5%)
Required Intervention 18 (0.5%)
O 17 (0.5%)
R 16 (0.4%)
Death 2 (0.1%)
S 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

False Positive Result 1,210
False Negative Result 606
Incorrect, Inadequate or Imprecise Result or Readings 111
High Test Results 38
Incorrect Or Inadequate Test Results 37
Adverse Event Without Identified Device or Use Problem 36
No Apparent Adverse Event 22
Low Test Results 11
Non Reproducible Results 6
Unable to Obtain Readings 5
Insufficient Information 4
Product Quality Problem 4
Device Issue 2
Output Problem 2
Break 1
Device Ingredient or Reagent Problem 1
Device Operates Differently Than Expected 1
Display Difficult to Read 1
Display or Visual Feedback Problem 1
High Readings 1

Yearly Trend

96
1996: 8
97
1997: 18
98
1998: 13
99
1999: 14
00
2000: 17
01
2001: 32
02
2002: 54
03
2003: 58
04
2004: 71
05
2005: 47
06
2006: 33
07
2007: 245
08
2008: 29
09
2009: 106
10
2010: 143
11
2011: 138
12
2012: 219
13
2013: 185
14
2014: 112
15
2015: 134
16
2016: 143
17
2017: 113
18
2018: 132
19
2019: 571
20
2020: 114
21
2021: 158
22
2022: 126
23
2023: 147
24
2024: 256
25
2025: 270
26
2026: 31

Related Entities for Visual, Pregnancy Hcg, Prescription Use

Event Locations

2,387 (63.9%)
I 1,256 (33.6%)
HOSPITAL 23 (0.6%)
OUTPATIENT TREATMENT FACILITY 13 (0.3%)
INVALID DATA 12 (0.3%)
NO INFORMATION 12 (0.3%)
LABORATORY 10 (0.3%)
UNKNOWN 9 (0.2%)
OTHER 8 (0.2%)
AMBULATORY SURGICAL FACILITY 3 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.1%)
CLINIC - WALK IN, OTHER 1 (0.0%)
OUTPATIENT CLINIC/SURGERY 1 (0.0%)

Compare ALERE SAN DIEGO, INC. vs ALERE SAN DIEGO →

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.