FDA Adverse Event
Injury
Summary report: N
MICROPORE-SURGICAL TAPE 1X10YDSMICROPORE-SURGICAL TAPE 1X10YDS
MDR report key: 23568784
·
Received November 17, 2025
Report
- Report Number
- MW5178946
- Event Type
- Injury
- Date Received
- November 17, 2025
- Date of Event
- October 7, 2025
- Report Date
- November 13, 2025
- Manufacturer
- SOLVENTUM US LLC.
- Product Code
- KGX
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
- Health Professional
- *
Narratives
Description of Event or Problem · 0
A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE AND STATED THAT THE PAPER TAPE 16- 30SS-0 IRRITATED HIS SKIN AND DOES NOT NEED A REPLACEMENT. "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 |
|---|---|---|---|---|---|---|---|
| 2882646 | MICROPORE-SURGICAL TAPE 1X10YDSMICROPORE-SURGICAL TAPE 1X10YDS | TAPE AND BANDAGE, ADHESIVE | KGX | SOLVENTUM US LLC. | 16-30SS-0 | 33NLKA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |