MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-09-07 for ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVICE ABV320 manufactured by Convatec Inc..
[54153322]
Based on the available information, this event is deemed to be a reportable malfunction. Based on the available information, no patient harm occurred. No lot number is available. A detailed investigation or batch review cannot be conducted. Therefore this evaluation will be closed. This issue will be monitored through the post market product monitoring review process. Follow up has been requested, but no additional details have been provided to date. Should additional information become available, a follow-up report will be submitted. Reported to the fda on: september 07, 2016 (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[54153323]
Complaint reported that, "in icu, one (1) adviser kit, the autovalve did not disengage and prohibited urine flow. " reporter stated that "as far as she is aware there was no injury to the patient. " the abviser was removed and discontinued from the patient after this occurred. The unit was discarded by the icu. No further information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2016-00388 |
| MDR Report Key | 5934615 |
| Report Source | OTHER |
| Date Received | 2016-09-07 |
| Date of Report | 2016-08-12 |
| Date of Event | 2016-07-28 |
| Date Mfgr Received | 2016-08-12 |
| Date Added to Maude | 2016-09-07 |
| 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 | MRS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABVISER-INTRA ABDOMINAL PRESSURE MONITOR DEVICE |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2016-09-07 |
| Model Number | ABV320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC INC. |
| Manufacturer Address | 211 AMERICAN AVENUE GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-07 |