FDA Adverse Event
Malfunction
Summary report: N
TAPE AND BANDAGE, ADHESIVE
MDR report key: 24412881
·
Received February 23, 2026
Report
- Report Number
- MW5184169
- Event Type
- Malfunction
- Date Received
- February 23, 2026
- Date of Event
- January 16, 2026
- Report Date
- February 17, 2026
- Manufacturer
- SOLVENTUM GERMANY GMBH
- Product Code
- KGX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
DESCRIPTION OF REPORTED EVENT: A CAREGIVER OF A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED CUSTOMER SERVICE (CS) TO REPORT THE PATIENT HAD A REACTION TO THE MICROPORE-SURGICAL TAPE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 473179 | TAPE AND BANDAGE, ADHESIVE | TAPE AND BANDAGE, ADHESIVE | KGX | SOLVENTUM GERMANY GMBH | 108250807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |