MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-12-16 for ABVISER AUTOVALVE VALVE IAP MONITORING DEVIC ABV301 manufactured by Convatec, Inc..
[5203458]
It was reported the intra-abdominal pressure monitoring device was used on a newborn patient. The patient was reportedly suffering from "many complications" and had been previously admitted to the hospital's intensive therapy unit. On (b)(6) 2014, a nurse at the facility infused six milliliters in the pressure monitoring system and noted the autovalve did not activate. The nurse then unfused an additional two milliliters and again the autovalve did not activate. The patient reportedly expired on (b)(6) 2014. The device had been in use for thirty-nine days.
Patient Sequence No: 1, Text Type: D, B5
[12615360]
Based oin the available information, this event is deemed to be a death; however there is no allegation the death is device related. No further information was available at the time of the report. Should additional information become available, a follow-up report will be submitted. Reported to the fda on 12/16/2014.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2014-00622 |
| MDR Report Key | 4343298 |
| Report Source | 01,06 |
| Date Received | 2014-12-16 |
| Date of Report | 2014-11-19 |
| Date of Event | 2014-10-09 |
| Date Mfgr Received | 2014-11-19 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2014-12-18 |
| 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,INTERIM ASSOC D |
| 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 DEVIC |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2014-12-16 |
| Model Number | ABV301 |
| Lot Number | 130427 |
| Device Expiration Date | 2016-04-07 |
| 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 | 1. Death | 2014-12-16 |