MAUDE report

MAUDE report 10935: BASIC SHAVE PREP TRAY

Malfunction · received Jan 12, 1994 · PHARMASEAL DIV. BAXTER HEALTHCARE CORP.

Key facts

MDR report key 10935
Report number MW1000371
Event type Malfunction
Brand name BASIC SHAVE PREP TRAY
Catalog number 4405A
Manufacturer PHARMASEAL DIV. BAXTER HEALTHCARE CORP.
Product code LRP
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Jan 12, 1994
Report date Jan 11, 1994
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
  • None 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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