MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for PREVENA PLUS 125 PRI4001US manufactured by Kci Usa, Inc.
[185481271]
Wound vac pump would not work when attached to patient tubing. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093942 |
| MDR Report Key | 9888364 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-12-13 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREVENA PLUS 125 |
| Generic Name | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP |
| Product Code | OMP |
| Date Received | 2020-03-26 |
| Model Number | PRI4001US |
| Lot Number | 6826911V003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KCI USA, INC |
| Manufacturer Address | SAN ANTONIO TX 78249 US 78249 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |