MAUDE report

MAUDE report 83716: SUB-Q SET SUBCUTANEOUS INFUSION SET

Injury · received Apr 11, 1997 · BAXTER HEALTHCARE CORP.

Key facts

MDR report key 83716
Report number 6000001-1997-00383
Event type Injury
Brand name SUB-Q SET SUBCUTANEOUS INFUSION SET
Catalog number 1M8463
Manufacturer BAXTER HEALTHCARE CORP.
Product code FOZ
Device class Class II
Date received by FDA Apr 11, 1997
Report date Mar 14, 1997
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
  • 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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