MAUDE report

MAUDE report 15224: BIO MEDX PORTABLE AIR FLOTATION SYSTEM

Injury · received Aug 12, 1994 · SUNRISE BIO CLINIC CO

Key facts

MDR report key 15224
Report number MW1003087
Event type Injury
Brand name BIO MEDX PORTABLE AIR FLOTATION SYSTEM
Manufacturer SUNRISE BIO CLINIC CO
Product code INX
Device class Class II
Date received by FDA Aug 12, 1994
Report date Aug 3, 1994
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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