MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-04-22 for ABVISER AUTOVALVE IAP MONITORING DEVICE, POLE ABV301 manufactured by Convatec Inc..
[43447402]
Device manufacture date: 05/2016. Based on the available information, this event is deemed to be a reportable malfunction. Based on the available information, no patient harm occurred. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[43447403]
Reporter stated "the auto-valve was stuck and did not work. " reporter stated that the device had been in use for five (5) days when the issue occurred. Reporter provided no further details.
Patient Sequence No: 1, Text Type: D, B5
[47324008]
(expiration date) 09/2016. The batch record review indicates no discrepancies. The batch records manufactured from december 1, 2012 through may 31, 2013 (including lot# 130428), showed all functional testing met the specifications. This issue will be monitored through the post market monitoring review process. No additional patient/ event details have been provided to date. Should additional information become available, a follow-up report will be submitted. Reported to the fda on june 09, 2016.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2016-00182 |
| MDR Report Key | 5600751 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-04-22 |
| Date of Report | 2016-03-30 |
| Date of Event | 2016-03-24 |
| Date Mfgr Received | 2016-05-26 |
| Device Manufacturer Date | 2013-05-02 |
| Date Added to Maude | 2016-04-22 |
| 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 AUTOVALVE IAP MONITORING DEVICE, POLE |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2016-04-22 |
| Model Number | ABV301 |
| Lot Number | 130428 |
| 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 AVENUE GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-22 |