ERIKA DE REYNOSA, S.A. DE C.V.

FDA MAUDE device safety record · 1999–2026

What the Data Shows About ERIKA DE REYNOSA, S.A. DE C.V.

ERIKA DE REYNOSA, S.A. DE C.V. is associated with 17,699 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1999 through 2026. Of the total, 196 are coded as death reports and 5,735 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 11 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for ERIKA DE REYNOSA, S.A. DE C.V. should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 11,766 reports (66.5% of total). Patient-outcome categorizations are reported across 12 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 18 years of MAUDE data, with the peak single-year volume reaching 3,130 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

17,699
Total Reports
196
Death Reports
5,735
Injury Reports
11
Device Types

Event Types

Malfunction 11,766 (66.5%)
Injury 5,735 (32.4%)
Death 196 (1.1%)
1 (0.0%)
Other 1 (0.0%)

Patient Outcomes

11,825 (56.3%)
Required Intervention 3,541 (16.9%)
Hospitalization 2,066 (9.8%)
R 2,048 (9.8%)
H 1,147 (5.5%)
Death 173 (0.8%)
L 76 (0.4%)
Other 46 (0.2%)
D 41 (0.2%)
Life Threatening 24 (0.1%)
O 8 (0.0%)
S 1 (0.0%)

Yearly Trend

99
1999: 1
04
2004: 2
06
2006: 1
12
2012: 5
13
2013: 19
14
2014: 5
15
2015: 9
16
2016: 110
17
2017: 1,186
18
2018: 2,088
19
2019: 1,966
20
2020: 1,922
21
2021: 1,924
22
2022: 1,776
23
2023: 1,496
24
2024: 1,646
25
2025: 3,130
26
2026: 413

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 manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.