MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-01 for LINVATEC * 9905A manufactured by Linvatec Corp.
[314717]
Pt sustained 2nd degree burn from linvatec traction tower during surgery. Tower was flashed, allowed to cool approx 21 mins and felt only slightly warm to touch to surgeon and ort prior to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1033156 |
| MDR Report Key | 562855 |
| Date Received | 2004-11-01 |
| Date of Report | 2004-11-01 |
| Date of Event | 2004-10-25 |
| Date Added to Maude | 2005-01-05 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINVATEC |
| Generic Name | TRACTION TOWER DEVICE |
| Product Code | ILZ |
| Date Received | 2004-11-01 |
| Model Number | * |
| Catalog Number | 9905A |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 552580 |
| Manufacturer | LINVATEC CORP |
| Manufacturer Address | 11311 CONCEPT BLVD LARGO FL 33773 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-11-01 |