MAUDE report

MAUDE report 99: SAFESKIN

Injury · received Feb 19, 1992 · SAFESKIN CORPORATION

Key facts

MDR report key 99
Report number 99
Event type Injury
Brand name SAFESKIN
Model number 400 AND 300
Catalog number UNKNOWN
Manufacturer SAFESKIN CORPORATION
Product code LYY
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Feb 19, 1992
Report date Feb 4, 1992
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
  • 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