MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for PREVENA PLUS ISCISIONAL MANAGEMENT SYSTEM 60300EP PRE4001US manufactured by Kci Usa, Inc..
[185223597]
Surgeon attempted to put prevena wound vac on pt. Wound vac sponge would not keep suction. Surgeon said that the prevena canister would not seat onto the prevena wound vac machine properly. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093934 |
| MDR Report Key | 9883216 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-21 |
| Date Added to Maude | 2020-03-26 |
| 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 ISCISIONAL MANAGEMENT SYSTEM |
| Generic Name | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP |
| Product Code | OMP |
| Date Received | 2020-03-25 |
| Model Number | 60300EP |
| Catalog Number | PRE4001US |
| Lot Number | 7149887V003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KCI USA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |