MAUDE report

MAUDE report 70122: IVORY RUBBER DAM CLAMP

Malfunction · received Feb 14, 1997 · HERAEUS KULZER INC

Key facts

MDR report key 70122
Report number 2411236-1997-00849
Event type Malfunction
Brand name IVORY RUBBER DAM CLAMP
Model number 7A
Catalog number 990 7033
Manufacturer HERAEUS KULZER INC
Product code EEF
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Feb 14, 1997
Report date Jan 9, 1997
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
  • 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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