MAUDE report

MAUDE report 32025: O-POLYSORB

Malfunction · received Apr 15, 1996 · UNITES STATES SURGICAL CORP.

Key facts

MDR report key 32025
Report number MW1008878
Event type Malfunction
Brand name O-POLYSORB
Catalog number CL-844
Manufacturer UNITES STATES SURGICAL CORP.
Product code GAM
Device class Class II
Date received by FDA Apr 15, 1996
Report date Apr 15, 1996
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
  • None Death reports for this brand
  • None Injury reports for this brand
  • 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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