FDA Adverse Event
Malfunction
Summary report: N
NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
MDR report key: 17523407
·
Received August 12, 2023
Report
- Report Number
- MW5130355
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- September 10, 2015
- Manufacturer
- INNOVATIVE THERAPIES INC, 12 MEEM AVENUE, SUITE C,
- Product Code
- OMP
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
CANISTER HAS DRAINAGE IN IT BUT THE SOLIDIFIER DID NOT ACTIVATE AND CAUSE DRAINAGE TO SOLIDIFY. REPLACEMENT ISSUED. CALLED IN FOR 3 CANISTERS WITH THE SAME LOT TO BE REPLACED - NO CHARGE FOR THE CURRENT CANISTER. INVACARE PRID # (B)(4). 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 |
|---|---|---|---|---|---|---|---|
| 2234172 | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP | OMP | INNOVATIVE THERAPIES INC, 12 MEEM AVENUE, SUITE C, |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |