MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-02-23 for manufactured by .
| Report Number | 2017233-2006-00037 |
| MDR Report Key | 680212 |
| Report Source | 05,06 |
| Date Received | 2006-02-23 |
| Date of Event | 2005-08-25 |
| Date Mfgr Received | 2006-02-07 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2006-03-02 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MONIKA ZAFFUTO |
| Manufacturer Street | 1500 N. FOURTH ST |
| Manufacturer City | FLAGSTAFF AZ 86004 |
| Manufacturer Country | US |
| Manufacturer Postal | 86004 |
| Manufacturer Phone | * |
| Manufacturer G1 | W.L. GORE & ASSOCIATES |
| 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 |
| Product Code | FIQ |
| Date Received | 2006-02-23 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 669477 |
| Baseline Brand Name | THINWALLED GORE-TEX STRETCH VASCGRAFT CONFIG FOR PEDIA.SHUNT |
| Baseline Generic Name | EPTFE VASCULAR PROSTHESIS |
| Baseline Model No | WLG211 |
| Baseline Catalog No | ST05010 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-23 |