MAUDE report

MAUDE report 353

Malfunction · received Mar 27, 1992 · HILLROM

Key facts

MDR report key 353
Report number 353
Event type Malfunction
Catalog number 301
Manufacturer HILLROM
Product code FNJ
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Mar 27, 1992
Report date Mar 18, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • No Adverse event flagged
  • Yes 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:

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