MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-04-01 for ABVISER AUTOVALVE VALVE IAP MONITORING DEVICE ABV601 manufactured by Convatec, Inc..
[5759595]
The nurse reports a patient in the hospital for diabetic coma. It was further reported the abviser iap monitoring device was in place four days when the nurse noted the device didn't work correctly. The nurse stated the device was removed and when connected to the urine drainage bag approximately four hundred milliliters of urine was obtained; the nurse estimates the patient had no urine output for approximately four hours. The nurse further reports the patient had no complications based on this event and the device was discontinued.
Patient Sequence No: 1, Text Type: D, B5
[13175930]
Based on the available information, this event is deemed a reportable malfunction. There were no reports of the patient being harmed as a result of this malfunction. Additional patient/event details have been requested. Should additional information become available a follow-up report will be submitted. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2015-00183 |
| MDR Report Key | 4652204 |
| Report Source | 01,05,06 |
| Date Received | 2015-04-01 |
| Date of Report | 2015-03-18 |
| Date of Event | 2015-01-17 |
| Date Mfgr Received | 2015-03-18 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2015-05-13 |
| 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, DIRECTOR |
| 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 AUTOVALVE VALVE IAP MONITORING DEVICE |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2015-04-01 |
| Model Number | ABV601 |
| Lot Number | 130554 |
| Device Expiration Date | 2016-06-12 |
| 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 | 2015-04-01 |