InjuryILG
COMPERM
Received Sep 18, 2017 · Event occurred Aug 11, 2017
Report 1218946-2017-00001 · MDR key 6871872
Device
Product problems
- Device Markings/Labelling Problem
- Device Markings/Labelling Problem
Patient
Not reported
- Skin Inflammation
- Skin Inflammation
Narrative
Additional Manufacturer Narrative
THE LOT NUMBER OF THE PRODUCT, PATIENT AGE, WEIGHT, ETHNICITY/RACE OR SEX WAS NOT GIVEN BY THE CUSTOMER. HARTMANN USA HAS UPDATED THE PRODUCT LITERATURE TO STATE THE PRODUCT CONTAINS POLYESTER. (B)(4).
Description of Event or Problem
THE CUSTOMER CALLED TO FIND OUT IF COMPERM CONTAINED POLYESTER OR NYLON. THE CUSTOMER USED COMPERM ON A PATIENT WITH KNOWN ALLERGIES TO NYLON AND POLYESTER AND THE PATIENT HAD AN ALLERGIC REACTION. THE SKIN PRODUCED A RASH.
Remedial action
- Other