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 |