MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-06-28 for CONTOUR PVA MICROSPHERES UNK90 manufactured by Boston Scientific - Costa Rica (coyol).
[78655398]
Device evaluation by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[78655399]
It was reported that the patient experienced pain and an allergic reaction. Four months post a contour implant procedure the patient experienced a sharp burning pain and an allergic reaction. At the time of reporting it was unknown if the patient received any pain treatment or treatment for the allergic reaction. No further patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2017-06403 |
| MDR Report Key | 6674799 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-06-28 |
| Date of Report | 2017-06-06 |
| Date Mfgr Received | 2017-06-06 |
| Date Added to Maude | 2017-06-28 |
| 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. SONALI ARANGIL |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Street | 2546 FIRST STREET PROPARK FREE ZONE |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTOUR PVA MICROSPHERES |
| Generic Name | AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS |
| Product Code | NAJ |
| Date Received | 2017-06-28 |
| Model Number | UNK90 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Address | 2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-28 |