MAUDE report

MAUDE report 66919: PCA 10 HOOD INSERT 32X58/61MM

Malfunction · received Jan 31, 1997 · HOWMEDICA, INC.

Key facts

MDR report key 66919
Report number 2219689-1997-00057
Event type Malfunction
Brand name PCA 10 HOOD INSERT 32X58/61MM
Catalog number 6283-7-581
Manufacturer HOWMEDICA, INC.
Product code KWB
Device class Class III
Date received by FDA Jan 31, 1997
Report date Jan 30, 1997
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
  • 1–9 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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