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
Manufacturer
Medline Industries, Inc.Model number
NON27457MLot 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.