MAUDE report

MAUDE report 21537: PHARMASEAL

Injury · received Aug 2, 1993 · BAXTER HELTHCARE CORPORATION

Key facts

MDR report key 21537
Report number 21537
Event type Injury
Brand name PHARMASEAL
Catalog number 4341 A
Manufacturer BAXTER HELTHCARE CORPORATION
Product code FFA
Device class Class II
Date received by FDA Aug 2, 1993
Report date Jun 22, 1993
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • None Death reports for this brand
  • 10–99 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:

Browse all MAUDE medical device reports