NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
Received Jun 11, 2019 · Event occurred May 24, 2019
Report 1119193-2019-00023 · MDR key 8687597
Device
Generic name
New Image Ceraplus Skin Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
11204
Lot number
UNKNOWN
Product problems
- Loss of or Failure to Bond
- Leak/Splash
Patient
76 YR
- Tissue Damage
- Tissue Damage
Narrative
Additional Manufacturer Narrative
BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH ISO 10993 AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. DHR REVIEW NOT POSSIBLE BECAUSE NOT NUMBER NOT KNOWN. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. THE ROOT CAUSE OF THE STOMA CONTENT LEAKAGE CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT THE END USER EXPERIENCED A BURNING AND ITCHING RASH ON HER SKIN FROM HER KNEES TO HER WAIST FROM ILEOSTOMY OUTPUT. SHE REPORTED THAT WHEN THE HOLLISTER BARRIER GOT WET FROM HER OUTPUT, IT WOULD NOT ADHERE TO HER SKIN AND LEAK. SHE WENT TO THE ER AND WAS HOSPITALIZED OVERNIGHT. SHE WAS DISCHARGED HOME ON CIPROFLOXACIN AND FLUCONAZOLE. HOLLISTER IS SENDING HER A CONVEX BARRIER PRODUCT TO TRY.