FDA Adverse Event
Malfunction
Summary report: N
POCKET PRESS CIED
MDR report key: 21604976
·
Received March 14, 2025
Report
- Report Number
- 21604976
- Event Type
- Malfunction
- Date Received
- March 14, 2025
- Date of Event
- January 9, 2025
- Report Date
- March 3, 2025
- Manufacturer
- COMPRESS INNOVATIONS, LLC
- Product Code
- FQM
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT HAD A DEVICE PLACED WITH A DRESSING OVER THE TOP. WHEN THE DRESSING WAS REMOVED A SKIN TEAR OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1112018 | POCKET PRESS CIED | BANDAGE, ELASTIC | FQM | COMPRESS INNOVATIONS, LLC | PKT21 | 240218 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |