MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-07-12 for ABVISER AUTOVALVE?IAP MONITORING DEVICE ABV301 manufactured by Convatec, Inc..
[49384039]
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 not provided to date. If additional information becomes available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[49384040]
Complaint received from a dealer reporting that an auto-valve malfunction had occurred with the device. Reporter after thirty-six (36) hours of usage, the auto-valve did not open which resulted in the urine and saline not being able to drain;the device was replaced. The patient required the device for blunt abdominal trauma and has since recovered. No further patient information, including medical history, was provided.
Patient Sequence No: 1, Text Type: D, B5
[50542172]
This supplemental is being submitted as an used product sample has been returned for evaluation. The product sample was decontaminated and forwarded to the original equipment manufacturer (oem) for further investigation. No additional patient/event 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
[51290441]
A batch record review for lot# 140600 was performed by the original equipment manufacturer (oem), and showed that all functional testing met the specification. The valve was opened and evaluated under the microscope. It exhibited that the valve was assembled correctly. The filter was clean, but the 0. 0015" timing hole was completely clogged with some foreign particulate. The particulate was too small in size to determine the exact source. This issue will be monitored through the post market product monitoring review process. Several photos were also received regarding the reported event. No additional patient/event 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
| Report Number | 1049092-2016-00309 |
| MDR Report Key | 5787641 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-07-12 |
| Date of Report | 2016-06-23 |
| Date Mfgr Received | 2016-07-29 |
| Device Manufacturer Date | 2014-06-02 |
| Date Added to Maude | 2016-07-12 |
| 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 | 2016-07-12 |
| Returned To Mfg | 2016-06-28 |
| Model Number | ABV301 |
| Lot Number | 140600 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC, INC. |
| Manufacturer Address | 211 AMERICAN AVENUE, SUITE 400 GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-12 |