MAUDE report

MAUDE report 43954: PACER ACCUMILL-P

Malfunction · received Oct 21, 1996 · BOEHRINGER MANNHEIM CORP.

Key facts

MDR report key 43954
Report number MW1010118
Event type Malfunction
Brand name PACER ACCUMILL-P
Model number ACCUM ILLP
Catalog number *
Manufacturer BOEHRINGER MANNHEIM CORP.
Product code IOL
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Oct 21, 1996
Report date Oct 10, 1996
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 MAUDE reports for this product code
  • 1–9 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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