MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-21 for manufactured by .
| Report Number | 1626179-1997-00001 |
| MDR Report Key | 64848 |
| Date Received | 1997-01-21 |
| Date of Event | 1996-06-03 |
| Date Mfgr Received | 1997-01-08 |
| Device Manufacturer Date | 1996-08-01 |
| Date Added to Maude | 1997-01-29 |
| 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 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | KTB |
| Date Received | 1997-01-21 |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 57396 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-01-21 |