MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-06-07 for UNK manufactured by Unk.
[643265]
Removal external fixator left ankle.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 864545 |
MDR Report Key | 864545 |
Report Source | 99 |
Date Received | 2007-06-07 |
Date of Report | 2007-05-22 |
Date of Event | 2007-03-21 |
Date Added to Maude | 2007-06-18 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 0 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | UNK |
Generic Name | UNK |
Product Code | NDK |
Date Received | 2007-06-07 |
Model Number | UNK |
Catalog Number | UNK |
Lot Number | UNK |
ID Number | UNK |
Device Age | NA |
Device Eval'ed by Mfgr | * |
Implant Flag | N |
Device Sequence No | 1 |
Device Event Key | 847708 |
Manufacturer | UNK |
Manufacturer Address | UNK UNK |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Other | 2007-06-07 |