MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2015-11-05 for ABVISER AUTOVALVE IAP MONITORING DEVICE, PATIENT MOUNT ABV601 manufactured by Wolfe Tory Medical Inc.
[30546261]
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4). Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
Patient Sequence No: 1, Text Type: N, H10
[30546262]
Customer reported that on couple occasions autovalve failed to do it's work and resulted with retention of fluid in patients bladder. On one occasion it resulted with retention of 1. 5l of fluid which nearly caused serious complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722554-2015-31258 |
| MDR Report Key | 5205307 |
| Report Source | FOREIGN |
| Date Received | 2015-11-05 |
| Date of Report | 2014-02-27 |
| Date Mfgr Received | 2014-02-27 |
| Device Manufacturer Date | 2012-05-17 |
| Date Added to Maude | 2015-11-05 |
| 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, PATIENT MOUNT |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2015-11-05 |
| Model Number | ABV601 |
| Lot Number | 120529 |
| Device Expiration Date | 2015-05-17 |
| 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 | 1. Required No Informationntervention | 2015-11-05 |