MAUDE report

MAUDE report 4153

Malfunction · received Jul 20, 1992 · MALLINCKRODT

Key facts

MDR report key 4153
Report number 4153
Event type Malfunction
Manufacturer MALLINCKRODT
Product code BSK
Device class Class II
Date received by FDA Jul 20, 1992
Report date May 19, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 MAUDE reports for this product code
  • 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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