MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2003-07-18 for DURA-GUARD UNK * manufactured by Synovis Surgical Innovations.
[292340]
In 06/2003 manufacturer was notified of a pt who exhibited what appeared to be an acute inflammatory response following implantation of dura-guard (exact date unk). The device was then explanted (2003, exact date unk) resulting in a reduction of the pt's symptoms. Pt status was then assessed as "better".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183620-2003-00014 |
| MDR Report Key | 472703 |
| Report Source | 01,05,08 |
| Date Received | 2003-07-18 |
| Date of Report | 2003-06-23 |
| Date of Event | 2003-06-01 |
| Date Mfgr Received | 2003-06-23 |
| Date Added to Maude | 2003-07-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PAUL HARTZELL |
| Manufacturer Street | 2575 UNIVERSITY AVENUE, W |
| Manufacturer City | ST. PAUL MN 55114 |
| Manufacturer Country | US |
| Manufacturer Postal | 55114 |
| Manufacturer Phone | 6516033732 |
| Manufacturer G1 | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Street | 2575 UNIVERSITY AVE W |
| Manufacturer City | ST PAUL MN 55114 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55114 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURA-GUARD |
| Generic Name | DURAL REPAIR PATCH |
| Product Code | GXO |
| Date Received | 2003-07-18 |
| Model Number | UNK |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 461556 |
| Manufacturer | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Address | 2575 UNIVERSITY AVE., WEST ST. PAUL MN 55114 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2003-07-18 |