MAUDE report

MAUDE report 50670: CHEMO GLOVE

Malfunction · received Nov 21, 1996 · BIO SAFETY SYSTEMS, INC.

Key facts

MDR report key 50670
Report number MW1010305
Event type Malfunction
Brand name CHEMO GLOVE
Model number UNK
Catalog number UNK
Manufacturer BIO SAFETY SYSTEMS, INC.
Product code LYY
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Nov 21, 1996
Report date Nov 13, 1996
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
  • None Injury reports for this brand
  • No 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:

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