MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-03-20 for * manufactured by W.l. Gore & Associates,inc.
[18719544]
A review of the manufacturing paperwork has been conducted. The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017233-2008-00120 |
| MDR Report Key | 1020165 |
| Report Source | 05,06,07 |
| Date Received | 2008-03-20 |
| Date Mfgr Received | 2008-03-05 |
| Device Manufacturer Date | 2007-04-01 |
| Date Added to Maude | 2008-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHARLES SILVER |
| Manufacturer Street | 1505 N FOURTH ST |
| Manufacturer City | FLAGSTAFF AZ 86004 |
| Manufacturer Country | US |
| Manufacturer Postal | 86004 |
| Manufacturer Phone | 9288644353 |
| Manufacturer G1 | W. L. GORE & ASSOCIATES, INC |
| Manufacturer Street | 1505 N FOURTH ST |
| Manufacturer City | FLAGSTAFF AZ 86004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Product Code | FIQ |
| Date Received | 2008-03-20 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 987311 |
| Manufacturer | W.L. GORE & ASSOCIATES,INC |
| Manufacturer Address | 1505 NORTH FOURTH ST. FLAGSTAFF AZ 860033000 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-20 |