MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-14 for ABVISER AUTOVALVE manufactured by Convatec, Inc..
[127125286]
Bladder pressure monitoring device in use. 40cc intravascular fluid (ivf) instilled and device controlled to release fluid after 2-3 minutes. Patient with no urinary output for several hours despite bladder pressure monitoring and instilled ivf into bladder. Removed device, 70cc urine drained from bladder. Device malfunctioned and was not releasing urine or fluid. No patient harm or change in care due to malfunction. No model number or serial number on device as container was thrown away upon initiation. Device not available for return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8068606 |
| MDR Report Key | 8068606 |
| Date Received | 2018-11-14 |
| Date of Report | 2018-10-26 |
| Date of Event | 2018-04-05 |
| Report Date | 2018-10-26 |
| Date Reported to FDA | 2018-10-26 |
| Date Reported to Mfgr | 2018-11-14 |
| Date Added to Maude | 2018-11-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABVISER AUTOVALVE |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2018-11-14 |
| Model Number | ABVISER AUTOVALVE |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC, INC. |
| Manufacturer Address | 7900 TRIAD CENTER DRIVE SUITE 400 GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-14 |