MAUDE report

MAUDE report 18545: MEDISTRAINTS SAFETY VEST, SIZE LARGE

Death · received Dec 27, 1994 · MEDLINE INDUSTRIES, INC.

Key facts

MDR report key 18545
Report number MW1004573
Event type Death
Brand name MEDISTRAINTS SAFETY VEST, SIZE LARGE
Model number MDT828134
Catalog number UNKNOWN
Manufacturer MEDLINE INDUSTRIES, INC.
Product code FMQ
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Dec 27, 1994
Report date Dec 12, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • None Injury reports for this brand
  • Yes Adverse event flagged
  • No Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

Browse all MAUDE medical device reports