MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-10-18 for BERCHTOLD OZ 1002530 * manufactured by Berchtold Corporation.
[19492544]
Bruising and skin indentation noticed when drapes removed caused from orthroscopic leg holder (padding faulty).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 778825 |
| MDR Report Key | 778825 |
| Date Received | 2006-10-18 |
| Date of Report | 2006-10-18 |
| Date of Event | 2006-10-10 |
| Report Date | 2006-10-18 |
| Date Reported to FDA | 2006-10-18 |
| Date Added to Maude | 2006-11-10 |
| 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 | 0 |
| 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 | BERCHTOLD |
| Generic Name | LEG HOLDER |
| Product Code | BWN |
| Date Received | 2006-10-18 |
| Model Number | OZ 1002530 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 766604 |
| Manufacturer | BERCHTOLD CORPORATION |
| Manufacturer Address | 1950 HANAHAN ROAD CHARLESTON SC 29406 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-18 |