MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-05 for ABVISER AUTOVALVE IAP MONITORING WITH TRANSDUCER, POLE MOUNT ABV321 manufactured by Wolfe Tory Medical Inc.
[30469681]
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4). Convatec is submitting this report pursuant to the provisions of 21cfr part 803. 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
[30469682]
It was reported that nurse applied abvisor to end user and once placed noted crack in green diaphragm and leaking. Nurse removed abvisor and replaced with new abvisor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722554-2015-31259 |
| MDR Report Key | 5204013 |
| Date Received | 2015-11-05 |
| Date of Report | 2014-02-27 |
| Date of Event | 2012-12-07 |
| Date Mfgr Received | 2014-02-27 |
| Device Manufacturer Date | 2012-07-23 |
| 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 |
| Lot Number | 120722 |
| Device Expiration Date | 2015-07-23 |
| Operator | NURSE |
| 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 |