MAUDE report

MAUDE report 18878: DISPOSABLE SURGICAL GOWN

Other · received Jan 9, 1995 · JOHNSON AND JOHNSON PRODUCTS

Key facts

MDR report key 18878
Report number MW1004701
Event type Other
Brand name DISPOSABLE SURGICAL GOWN
Manufacturer JOHNSON AND JOHNSON PRODUCTS
Product code FYA
Device class Class II
Date received by FDA Jan 9, 1995
Report date Dec 28, 1994
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
  • None 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