InjuryKGX
TRANSPORE-PLASTIC TRANS. TAPE 1"X10YDS
Received Jul 14, 2026 · Event occurred Apr 28, 2026
Report MW5190713 · MDR key 25816296
Device
Patient
NA · Unknown
- Hypersensitivity/Allergic reaction
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
A PERITONEAL DIALYSIS (PD) PATIENT'S SISTER CONTACTED FRESENIUS CUSTOMER SERVICE AND REPORTED THAT THE PATIENT IS ALLERGIC TO PLASTIC TAPE. THE PATIENT EXPERIENCED SKIN IRRITATION WHEN THE PLASTIC TAPE IS USED AND THAT THE TAPE MUST BE REMOVED DUE TO THE REACTION. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).