MAUDE report

MAUDE report 83140: AUTO SUTURE ROTICULATOR 55 POLY

Malfunction · received Apr 14, 1997 · AUTO SUTURE, US SURGICAL CORP.

Key facts

MDR report key 83140
Report number MW1011133
Event type Malfunction
Brand name AUTO SUTURE ROTICULATOR 55 POLY
Model number 013601
Catalog number *
Manufacturer AUTO SUTURE, US SURGICAL CORP.
Product code GAG
Device class Class II
Date received by FDA Apr 14, 1997
Report date Apr 11, 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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