MAUDE report

MAUDE report 403: JACK FROST

Injury · received Apr 17, 1992 · JACK FROST LABORATORIES

Key facts

MDR report key 403
Report number 403
Event type Injury
Brand name JACK FROST
Catalog number 0301 (REORDER NUMBER)
Manufacturer JACK FROST LABORATORIES
Product code IME
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Apr 17, 1992
Report date Apr 3, 1992
Report source Maude

At a glance

  • None Device problems coded
  • 100–999 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