MAUDE report

MAUDE report 8640: PCA

Injury · received Mar 3, 1994 · HOWMEDICA, INC.

Key facts

MDR report key 8640
Report number 33462-1994-01136
Event type Injury
Brand name PCA
Catalog number 6628-4-500
Manufacturer HOWMEDICA, INC.
Product code HSA
Device class Class III
Date received by FDA Mar 3, 1994
Report date Jan 20, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 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:

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