MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-11-05 for ABVISER AUTOVALVE IAP MONITORING WITH TRANSDUCER, POLE MOUNT ABV321 manufactured by Wolfe Tory Medical Inc.
[30545213]
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
[30545214]
It was reported urine retention with the abviser. Bladder pressure completed and within a few minutes they noted the 20ml of flush in the urimeter. She did not see any urine in the urimeter or bag. They did bladder pressures every 6 hours for approximately 3 days so approximately 11 infusions for a total of 220ml. They performed a bladder scan and it read 300ml. They removed the abviser autovalve; reconnected the urimeter tubing and 250ml of urine drained out. The first bladder pressure was performed at 10am and a cystogram performed around noon on the same day. Technician instilled dye for cystogram in the foley catheter port. Nurse reported autovalve remains inflated even after removing it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722554-2015-31257 |
| MDR Report Key | 5205240 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-11-05 |
| Date of Report | 2014-02-27 |
| Date Mfgr Received | 2014-02-27 |
| 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 WITH TRANSDUCER, POLE MOUNT |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2015-11-05 |
| Model Number | ABV321 |
| 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 |