FDA Adverse Event
Injury
Summary report: N
MICROPORE-PAPER TAPE
MDR report key: 23316194
·
Received October 16, 2025
Report
- Report Number
- MW5177500
- Event Type
- Injury
- Date Received
- October 16, 2025
- Date of Event
- September 9, 2025
- Report Date
- October 6, 2025
- Manufacturer
- 3M COMPANY
- Product Code
- KGX
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE REPORTING THAT THE 16-1535-0 MICROPORE-PAPER TAPE LEFT SOME IRRITATION IN 1 TO 2 SPOTS WHEN USING THE PRODUCT. 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 |
|---|---|---|---|---|---|---|---|
| 2253279 | MICROPORE-PAPER TAPE | TAPE AND BANDAGE, ADHESIVE | KGX | 3M COMPANY | 16-1535-0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |