InjuryMSA
46-001 ST COVADERM 4X4 25
Received May 3, 2001 · Event occurred Apr 4, 2001
Report 1123071-2001-00004 · MDR key 330560
Product problems
- Reaction
Patient
UNKNOWN
- Blister(s)
- Erythema
Narrative
Description of Event or Problem
DISTRIBUTOR RECEIVED REPORT FROM USER FACILITY REGARDING COVADERM. CONTACT AT USER FACILITY REPORTED THAT AT LEAST FOUR RESIDENTS HAD EXPERIENCED EXTREMELY RED SKIN WITH BLISTER-LIKE AREAS WHERE ADHESIVE PORTION OF BANDAGE CONTACTED PATIENT'S SKIN. USER FACILITY REPORTED THAT IN AT LEAST 2 OF THE 4 INCIDENTS, THE PATIENTS DEVELOPED BLISTERS UNDER THE ADHESIVE PORTION OF THE BANDAGE. AT THIS TIME, THE USER FACILITY HAS NOT PROVIDED ANY ADDITIONAL INFO REGARDING THE INCIDENTS. THESE INCIDENTS WILL BE REPORTED UNDER MEDWATCH REPORTS 1123071-2001-00004 THROUGH 1123071-2001-00007.