MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2004-10-18 for manufactured by .
| Report Number | 9610609-2004-00001 |
| MDR Report Key | 887081 |
| Report Source | 08 |
| Date Received | 2004-10-18 |
| Date Mfgr Received | 2004-08-31 |
| Device Manufacturer Date | 2004-03-01 |
| Date Added to Maude | 2007-08-01 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOSEF HEISS |
| Manufacturer Street | GARTENSTRASSE 104 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer Phone | 46192850 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | GZX |
| Date Received | 2004-10-18 |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 531395 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-18 |