MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-02 for ABVISER??AUTOVALVE??IAP MONITORING DEVICE manufactured by Convatec Inc..
[39519264]
Based on the available information, this event is deemed to be a serious injury. A used device was returned for evaluation; however no model or lot number was available. The device was sent to the manufacturer for evaluation. No additional details or patient data have been provided to date. Should additional information become available, a follow-up report will be submitted. Reported to the fda on march 02, 2016. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[39519265]
It was reported that the device failed to deflate. There was one (1) liter of urine found in the patient's bladder, when the issue was noticed. No lab test were conducted. The bladder was drained without issue after the device was discontinued. Additional information was received on (b)(6) 2016, noting that the patient had a blood clot that formed right at the abviser balloon and was clotted off and there was no device malfunction noted. There was no patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
[40346315]
The complaint sample was returned however, an evaluation was not performed and is pending. Once the investigation is complete, a follow-up report will be submitted. No additional details or patient data 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 | 1049092-2016-00073 |
| MDR Report Key | 5475048 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-02 |
| Date of Report | 2016-02-08 |
| Date Mfgr Received | 2016-03-04 |
| Date Added to Maude | 2016-03-02 |
| 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 | 2016-03-02 |
| 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 | 1. Required No Informationntervention | 2016-03-02 |