MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2015-11-06 for ABVISER AUTOVALVE IAP MONITORING DEVICE, POLE MOUNT ABV301 manufactured by Wolfe Tory Medical Inc.
[30643052]
Convatec is submitting this report as a result of activities related to convatec remediation (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[30643053]
It was reported that the connection between auto valve and drain bag is leaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722554-2015-31299 |
| MDR Report Key | 5208146 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-11-06 |
| Date of Report | 2014-02-27 |
| Date Mfgr Received | 2014-02-27 |
| Date Added to Maude | 2015-11-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEANETTE JOHNSON |
| Manufacturer Street | 211 AMERICAN AVE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3362973009 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABVISER AUTOVALVE IAP MONITORING DEVICE, POLE MOUNT |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2015-11-06 |
| Model Number | ABV301 |
| Lot Number | 11003D |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WOLFE TORY MEDICAL INC |
| Manufacturer Address | 79 WEST 4500 SOUTH SUITE 18 SALT LAKE CITY UT 84107 US 84107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-06 |