FDA Adverse Event
Injury
Summary report: N
DURAPORE SILK TAPE
MDR report key: 21018187
·
Received December 26, 2024
Report
- Report Number
- MW5163865
- Event Type
- Injury
- Date Received
- December 26, 2024
- Date of Event
- December 12, 2024
- Report Date
- December 20, 2024
- Manufacturer
- 3M HEALTH CARE LTD.
- 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 CUSTOMER SERVICE TO REPORT THAT HE IS ALLERGIC TO THE SILK TAPE. PATIENT HAS BEEN HAVING THIS ISSUE FOR AT LEAST 2 YEARS.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 |
|---|---|---|---|---|---|---|---|
| 2625662 | DURAPORE SILK TAPE | TAPE AND BANDAGE, ADHESIVE | KGX | 3M HEALTH CARE LTD. | 106766489 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |