MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-18 for CONTOUR PVA MICROSPHERES UNK90 manufactured by Boston Scientific - Cork.
[45473285]
Age at time of event: 18 years or older. Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. If there is any further relevant information, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[45473286]
It was reported that patients experienced pain requiring additional medical intervention. After use of contour? Pva microspheres in pelvic embolization procedures, patients experienced pain/severe ischemic pain requiring an epidural pump for treatment of the pain. No patient injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2016-04208 |
| MDR Report Key | 5665255 |
| Date Received | 2016-05-18 |
| Date of Report | 2016-04-22 |
| Date Mfgr Received | 2016-04-22 |
| Date Added to Maude | 2016-05-18 |
| 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 | EMP. LINDA LEIMER |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | BOSTON SCIENTIFIC - CORK |
| Manufacturer Street | BUSINESS AND TECHNOLOGY PARK MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CONTOUR PVA MICROSPHERES |
| Generic Name | AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS |
| Product Code | NAJ |
| Date Received | 2016-05-18 |
| Model Number | UNK90 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - CORK |
| Manufacturer Address | BUSINESS AND TECHNOLOGY PARK MODEL FARM ROAD CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-18 |