MAUDE report

MAUDE report 6027: PCA CLUSTER SHELL LINER

Injury · received Jul 19, 1993 · HOWMEDICA, INC.

Key facts

MDR report key 6027
Report number 34462-1993-00004
Event type Injury
Brand name PCA CLUSTER SHELL LINER
Catalog number 6285-7-469
Manufacturer HOWMEDICA, INC.
Product code JDJ
Device class Class II
Date received by FDA Jul 19, 1993
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 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
  • 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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