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Culture Media, Selective And Non-Differential

Open-data reference.

FDA MAUDE adverse event data · 1995–2026

What the Data Shows About Culture Media, Selective And Non-Differential

The FDA MAUDE database aggregates 534 adverse-event reports for Culture Media, Selective And Non-Differential spanning the period from 1995 through 2026. Of these, 0 are classified as death reports, 0 as injury reports, and 534 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 1 distinct event type and 2 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 14 distinct product-problem codes appear in the reports, with Incorrect, Inadequate or Imprecise Result or Readings topping the list at 445 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 11 years of MAUDE data, with the peak single-year volume reaching 337 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 4 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.

534
Total Reports
0
Death Reports
0
Injury Reports
534
Malfunctions

Event Types

Malfunction 534 (100.0%)

Patient Outcomes

533 (99.8%)
Other 1 (0.2%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 445
Contamination 48
Contamination of Device Ingredient or Reagent 16
False Negative Result 8
Device Markings/Labelling Problem 7
Device Ingredient or Reagent Problem 4
Microbial Contamination of Device 4
Device Contaminated During Manufacture or Shipping 2
Delivered as Unsterile Product 1
Device Contamination with Chemical or Other Material 1
Inaccurate Information 1
Incorrect Measurement 1
Manufacturing, Packaging or Shipping Problem 1
Packaging Problem 1

Yearly Trend

95
1995: 1
05
2005: 1
18
2018: 2
19
2019: 10
20
2020: 6
21
2021: 46
22
2022: 56
23
2023: 16
24
2024: 19
25
2025: 337
26
2026: 40

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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.