← 483 OBSERVATION EXPLORER

FDA 483 OBSERVATION · #178 OF 1,000 MOST-CITED

Report of Death or Serious Injury

FDA cited this observation 129 times across 123 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.

BY PROGRAM AREA
Devices129
BY FISCAL YEAR
FY20265
FY202516
FY20248
FY202316
FY20229
FY20219
FY20206
FY201918
FY201830
FY201712

How FDA worded it — real examples

An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.

Biofilm, Inc. · Vista, California · Devices · 2026-05-19

An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.

MicroTransponder, Inc. · Lakeway, Texas · Devices · 2026-03-19

An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.

BioTissue Holdings Inc · Doral, Florida · Devices · 2026-02-18

An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.

Mid Central Medical, LLC. · Saint Vincent, Minnesota · Devices · 2025-12-09

An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.

Intuitive Surgical, Inc. · Sunnyvale, California · Devices · 2025-11-05

An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.

Nevro Corporation · Redwood City, California · Devices · 2025-08-13

Related SPEQ references

Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.

Medical devices →

Examples are a representative sample of FDA's published inspection observations. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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