MAUDE report

MAUDE report 33241: INFANT AMBU BAG

Malfunction · received May 29, 1996 · OWENS-BRIGAM MEDICAL, INC.

Key facts

MDR report key 33241
Report number MW1009173
Event type Malfunction
Brand name INFANT AMBU BAG
Catalog number 7915
Manufacturer OWENS-BRIGAM MEDICAL, INC.
Product code BTM
Device class Class II
Date received by FDA May 29, 1996
Report date May 28, 1996
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
  • 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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