FDA Adverse Event
Malfunction
Summary report: N
3M
MDR report key: 21798477
·
Received April 8, 2025
Report
- Report Number
- 3014527682-2025-00005
- Event Type
- Malfunction
- Date Received
- April 8, 2025
- Date of Event
- April 2, 2025
- Report Date
- April 8, 2025
- Manufacturer
- 3M COMPANY/SOLVENTUM US LLC
- Product Code
- KKX
- PMA / PMN Number
- K801550
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE LOT NUMBER WAS NOT PROVIDED BY THE REPORTING FACILITY, SO ONLY THE PRIMARY DEVICE IDENTIFIER IS PROVIDED IN THIS REPORT DUE TO THE LOT NUMBER BEING UNKNOWN.
Description of Event or Problem · 0
UPON REMOVING THE IOBAN DRAPE AT THE END OF THE CASE IT WAS NOTED THAT THE SKIN WAS TEARING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 768952 | 3M | DRAPE IOBAN 23X33IN | KKX | 3M COMPANY/SOLVENTUM US LLC | 50707387559361 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |