MAUDE report

MAUDE report 38351: RESTORE 3.75X18 SELF-TAP

Injury · received Sep 18, 1996 · LIFECARE BIOMEDICAL, INC.

Key facts

MDR report key 38351
Report number 2184002-1996-00186
Event type Injury
Brand name RESTORE 3.75X18 SELF-TAP
Model number R9005-38-18
Catalog number R9005-38-18
Manufacturer LIFECARE BIOMEDICAL, INC.
Product code DZE
Device class Class II
Date received by FDA Sep 18, 1996
Report date Oct 8, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 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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