MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1996-12-09 for UNK * manufactured by Not Aware That Kodak Product Was Involved..
[19083076]
Refer to physician letter describing adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1315356-1996-90001 |
| MDR Report Key | 54936 |
| Report Source | 00 |
| Date Received | 1996-12-09 |
| Date Mfgr Received | 1996-10-09 |
| Date Added to Maude | 1996-12-13 |
| 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 | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | UNK |
| Product Code | IWZ |
| Date Received | 1996-12-09 |
| Model Number | NA |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 40939 |
| Manufacturer | NOT AWARE THAT KODAK PRODUCT WAS INVOLVED. |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-12-09 |