MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-05 for MTF ITEM# 058050 NA manufactured by Mtf.
[560417]
Broken component.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 807193 |
| MDR Report Key | 807193 |
| Date Received | 2007-01-05 |
| Date of Report | 2006-12-26 |
| Date of Event | 2006-12-06 |
| Date Facility Aware | 2006-12-06 |
| Report Date | 2006-12-26 |
| Date Reported to FDA | 2006-12-26 |
| Date Reported to Mfgr | 2006-12-26 |
| Date Added to Maude | 2007-01-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTF |
| Generic Name | TISSUE |
| Product Code | LMO |
| Date Received | 2007-01-05 |
| Model Number | ITEM# 058050 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 794698 |
| Manufacturer | MTF |
| Manufacturer Address | P.O. BOX 23308 NEWARK NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-01-05 |