MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2015-10-08 for ABVISER? AUTOVALVE? IAP MONITORING DEVICE ABV321 manufactured by Convatec, Inc..
[27813379]
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 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 (b)(6) 2015 (b)(6)
Patient Sequence No: 1, Text Type: N, H10
[27813380]
It is reported urine did not drain through the drainage tubing of the intra-abdominal pressure monitoring device. The issue was noted immediately upon connection. The device was disconnected and replaced. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[36621142]
No sample has been received. No unit was returned, so no physical analysis could be performed. Third party examined the historical batch records for the abv321 manufactured from 05 january 2015 to 11 june 2015, including lot number 150616 which showed that all samples tested met the specification. No previous investigations are available. After the detailed batch review, no discrepancies (including non-conformances/deviations) were found. There is not enough information to conclude the product did not meet specification and perform as intended. Product monitoring reviews will monitor for product trends if this issue were to reoccur. No further actions are required, and the complaint will be closed. No additional information was available at the time of the report. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2015-00584 |
| MDR Report Key | 5134947 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-10-08 |
| Date of Report | 2015-09-15 |
| Date of Event | 2015-09-14 |
| Date Mfgr Received | 2015-12-23 |
| Device Manufacturer Date | 2015-06-08 |
| Date Added to Maude | 2015-10-08 |
| 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 | JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3362973009 |
| Manufacturer G1 | CONVATEC, INC. |
| Manufacturer Street | 211 AMERICAN AVENUE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABVISER? AUTOVALVE? IAP MONITORING DEVICE |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2015-10-08 |
| Model Number | ABV321 |
| Lot Number | 150616 |
| Device Expiration Date | 2018-06-07 |
| 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 AVENUE GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-08 |