FDA Adverse Event
Injury
Summary report: N
MICROPORE-PAPER TAPE 1X10YDS W/DISPENSER
MDR report key: 22819302
·
Received August 15, 2025
Report
- Report Number
- MW5174664
- Event Type
- Injury
- Date Received
- August 15, 2025
- Date of Event
- July 31, 2025
- Report Date
- August 13, 2025
- Manufacturer
- 3M COMPANY
- Product Code
- KGX
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE STATING HE IS USING THE 16-1535-0, MICROPORE-PAPER TAPE 1X10 YARDS WITH/DISPENSER IS LEAVING BLISTERS ON HIS AREA. 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 |
|---|---|---|---|---|---|---|---|
| 1628407 | MICROPORE-PAPER TAPE 1X10YDS W/DISPENSER | TAPE AND BANDAGE, ADHESIVE | KGX | 3M COMPANY | (MODEL NUMBER16-1535-0) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |