MAUDE report

MAUDE report 13363: FLEXIFLO III

Injury · received May 18, 1994 · ROSS PRODUCTS DIV. ABBOTT LABORATORIES

Key facts

MDR report key 13363
Report number MW1002032
Event type Injury
Brand name FLEXIFLO III
Manufacturer ROSS PRODUCTS DIV. ABBOTT LABORATORIES
Product code LZH
Device class Class II
Date received by FDA May 18, 1994
Report date Apr 14, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 10–99 MAUDE reports for this brand
  • 1–9 Death reports for this brand
  • 1–9 Injury reports for this brand
  • Yes 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:

Browse all MAUDE medical device reports