MAUDE report

MAUDE report 6836: RADIAL JAW II GI

Injury · received Sep 24, 1993 · SYMBIOSIS

Key facts

MDR report key 6836
Report number 1219544-1993-00042
Event type Injury
Brand name RADIAL JAW II GI
Catalog number 1565
Manufacturer SYMBIOSIS
Product code FCL
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Sep 24, 1993
Report date Sep 7, 1993
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
  • 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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