MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-06-14 for CONTOUR PVA MICROSPHERES M0017600450 760045S manufactured by Boston Scientific - Cork.
[47311397]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[47311398]
It was reported that sterility was compromised a contour pva microspheres package for an individual unit was noted to have been opened when examined. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[55144524]
Device evaluated by mfr. : the device was received with it's original pouch. A visual inspection of the returned device found that the pouch was wrapped in plastic. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. There were no issues identified in the device history review that potentially relate this complaint to manufacturing. The most probable root cause is considered handling damage as the event occurred without direct patient contact. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[55144525]
It was reported that sterility was compromised. A contour pva microspheres package for an individual unit was noted to have been opened when examined. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2016-05416 |
| MDR Report Key | 5722734 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-06-14 |
| Date of Report | 2016-05-16 |
| Date Mfgr Received | 2016-08-23 |
| Date Added to Maude | 2016-06-14 |
| 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 | 3 |
| Brand Name | CONTOUR PVA MICROSPHERES |
| Generic Name | AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS |
| Product Code | NAJ |
| Date Received | 2016-06-14 |
| Returned To Mfg | 2016-05-27 |
| Model Number | M0017600450 |
| Catalog Number | 760045S |
| Lot Number | 18200985 |
| Device Expiration Date | 2018-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-06-14 |