MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-11-28 for LONE START MEDICAL PRODUCTS INC * manufactured by Lone Star Medical Products.
[571741]
Lone start retractor system - retractor rings. Product was unable to be used because the screw on one side of the retractor was not working.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1041173 |
| MDR Report Key | 787460 |
| Date Received | 2006-11-28 |
| Date of Report | 2006-11-16 |
| Date of Event | 2006-11-16 |
| Date Added to Maude | 2006-11-29 |
| 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 |
| 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 | LONE START MEDICAL PRODUCTS INC |
| Generic Name | SURGICAL RETRACTOR |
| Product Code | GZD |
| Date Received | 2006-11-28 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 7074 |
| ID Number | REF# 3304G |
| Device Expiration Date | 2010-09-01 |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 775228 |
| Manufacturer | LONE STAR MEDICAL PRODUCTS |
| Manufacturer Address | 11211 CASH ROAD STAFFORD TX 77477 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-28 |