MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-07-07 for ABVISER-INTRA ABD PRESSURE MONITOR DEVICE ABV301 manufactured by Convatec Inc..
[4708419]
It is reported that after injection, for a while the auto valve was still closed and could not be opened automatically resulting in the device being removed because it could not be used in the pt.
Patient Sequence No: 1, Text Type: D, B5
[12343797]
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. Additional quality info received on (b)(4) 2014 states that there were six (6) reported complaints appeared to be related to the autovalve. No additional pt/event details have been provided to date. A return sample for evaluation is not expected. Should additional information become available, a follow up report will be submitted. Reported to the fda on (b)(4) 2014. Convatec will continue to track and monitor such complaints according to convatec inc's. Complaint handling and capa procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2014-00272 |
| MDR Report Key | 4012684 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-07-07 |
| Date of Report | 2014-06-12 |
| Date of Event | 2014-06-11 |
| Date Mfgr Received | 2014-06-12 |
| Date Added to Maude | 2014-08-26 |
| 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, INT ASSO DIR |
| 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-INTRA ABD PRESSURE MONITOR DEVICE |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2014-07-07 |
| Model Number | ABV301 |
| Catalog Number | ABV301 |
| Lot Number | 11003D |
| 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 | 2014-07-07 |