MAUDE report

MAUDE report 38656: P.F.C. BIPOLAR HEAD LINER COMPONENT

Injury · received Sep 19, 1996 · JOHNSON & JOHNSON PROFESSIONAL, INC.

Key facts

MDR report key 38656
Report number 1219655-1996-00002
Event type Injury
Brand name P.F.C. BIPOLAR HEAD LINER COMPONENT
Catalog number 85-8263
Manufacturer JOHNSON & JOHNSON PROFESSIONAL, INC.
Product code KWB
Device class Class III
Date received by FDA Sep 19, 1996
Report date Sep 19, 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
  • 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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