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 |