MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-07-24 for ABVISER-INTRA ABD PRESSURE MONITOR DEVICE ABV300 manufactured by Convatec Inc.
[4816967]
It is reported that the abviser device was installed to monitor iap (intra abdominal pressure) and connected to a #14 foley catheter and urine collecting bag cistoflo. The iap (intra abdominal pressure) measurement was performed for a day, however, in the measurement was performed for a day, however in the measurement of the second day at night the valve system did not deflate and collapse urine output for four (4) hours resulting in the removal of the device twenty four (24) hours of use. It is further reported that the obstruction in urine is associated with the device being in place; therefore it was decided to remove the device.
Patient Sequence No: 1, Text Type: D, B5
[12219206]
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. No additional patient/event details have been provided to date. A return sample for evaluation is not expected. Should additional information becomes available, a follow-up report will be submitted. Additional quality evaluation performed on (b)(4) 2014 states that there were (b)(4) reports noted in records for urine retention, one of which was within the past year.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2014-00345 |
| MDR Report Key | 3982689 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-07-24 |
| Date of Report | 2014-07-07 |
| Date of Event | 2014-07-05 |
| Date Mfgr Received | 2014-07-07 |
| Date Added to Maude | 2014-08-20 |
| 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, INTER ASSOC DI |
| 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-INTRA ABD PRESSURE MONITOR DEVICE |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2014-07-24 |
| Model Number | ABV300 |
| Catalog Number | ABV300 |
| Lot Number | 131038 |
| 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 | 2014-07-24 |