MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-03-04 for ABVISER AUTOVALVE VALVE IAP MONITORING DEVICE ABV301 manufactured by Convatec Inc..
[18071790]
A nurse reported that the device was placed in the pt on (b)(6) 2015 and after many tries, it was noted that the device was not working correctly as it presented both negative values and high values in the same time. The nurse further reported that the device was removed on the same day.
Patient Sequence No: 1, Text Type: D, B5
[18558076]
Based on the available info, this event is deemed a reportable malfunction. There were no reports of the pt being harmed as a result of this malfunction. No additional pt/event details have been provided to date. Should additional info become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2015-00129 |
| MDR Report Key | 4579988 |
| Report Source | 01,05,06 |
| Date Received | 2015-03-04 |
| Date of Report | 2015-02-09 |
| Date of Event | 2015-01-30 |
| Date Mfgr Received | 2015-02-09 |
| Date Added to Maude | 2015-04-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, INTERIM ASSOC |
| Manufacturer Street | 211 AMERICAN AVE. |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABVISER AUTOVALVE VALVE IAP MONITORING DEVICE |
| Product Code | FEN |
| Date Received | 2015-03-04 |
| Model Number | ABV301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC INC. |
| Manufacturer Address | 211 AMERICAN AVE GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-04 |