MAUDE report

MAUDE report 71265: RELIANCE SIZE/PK UNK

Injury · received Feb 21, 1997 · UROMED CORP.

Key facts

MDR report key 71265
Report number 1224675-1997-00012
Event type Injury
Brand name RELIANCE SIZE/PK UNK
Model number SIZE 4
Catalog number UNK
Manufacturer UROMED CORP.
Product code MNG
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Feb 21, 1997
Report date Feb 12, 1997
Report source Maude

At a glance

  • None Device problems coded
  • 10–99 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
  • Yes Adverse event flagged
  • No 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