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PREVENTION PLUS CHEMO ISOLATION GOWN

Received Nov 30, 2011 · Event occurred Oct 27, 2011

Report 1417592-2011-00060 · MDR key 2362240

Device

Generic name

Isolation Gown

Model number

NON27457M

Lot number

1051824992

Product problems

  • Patient-Device Incompatibility

Patient

UNK

  • Hypersensitivity/Allergic reaction
  • Reaction

Narrative

Additional Manufacturer Narrative

WHEN THE CLINICIAN PUT ON THE GOWN, SHE IMMEDIATELY EXPERIENCED A RASH AROUND HER MOUTH AND ON HER FACE. SHE ALSO HAD DIFFICULTY BREATHING. SHE IS A KNOWN ASTHMATIC WITH MULTIPLE ALLERGIES. SHE USED HER INHALER, WAS SEEN BY THE OCCUPATIONAL HEALTH PRACTITIONER AND THEN GIVEN AN ANTIHISTAMINE WITH GOOD RESULTS. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. WE HAVE NOT RECEIVED ANY OTHER SIMILAR COMPLAINTS FOR THIS PRODUCT. NO CORRECTIVE ACTION IS INDICATED AT THIS TIME.

Description of Event or Problem

A CLINICIAN DEVELOPED A SEVERE ALLERGIC REACTION AFTER PUTTING ON THE GOWN.