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 |