MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-10-06 for ABVISER??AUTOVALVE??IAP MONITORING DEVICE ABV301 manufactured by Convatec Inc..
[56935523]
Expiration date (05/2017). Based on the available information, this event is deemed to be a reportable malfunction. No patient harm was reported. Additional details have been requested but none provided to date. The device has been returned for evaluation and was forwarded to the manufacturer for further investigation. Should additional information become available, a follow-up report will be submitted. Reported to the fda on october 06, 2016. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[56935524]
The reporter stated, "on third day of usage (approximately 70 hours), the nurse discovered that there was no urine output from the patient. After checking all the possible reasons, the auto-valve was found not deflated. " reporter stated that the device was replaced. No patient harm was reported. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2016-00418 |
| MDR Report Key | 6002576 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-10-06 |
| Date of Report | 2016-09-19 |
| Date of Event | 2016-09-12 |
| Date Mfgr Received | 2016-09-19 |
| Device Manufacturer Date | 2014-06-02 |
| Date Added to Maude | 2016-10-06 |
| 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 |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2016-10-06 |
| Returned To Mfg | 2016-09-26 |
| Model Number | ABV301 |
| Lot Number | 140600 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-10-06 |