MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-30 for LSL INDUSTRIES, INC. FUTURA SAFETY SCALPEL 680211 manufactured by Lsl Industries, Inc.
[665778]
Futura safety scalpel was closed after use. When it closed the inner portion shot out the back of the outer portion, flew across the room and hit the wall. Obvious the device is defective. The scalpel was part of a pre-packaged sterile incision and drainage tray deluxe from lsl industries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003228 |
| MDR Report Key | 888647 |
| Date Received | 2007-07-30 |
| Date of Report | 2007-07-30 |
| Date of Event | 2007-07-26 |
| Date Added to Maude | 2007-08-09 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LSL INDUSTRIES, INC. FUTURA SAFETY SCALPEL |
| Generic Name | SAFETY SCALPEL |
| Product Code | GDX |
| Date Received | 2007-07-30 |
| Model Number | 680211 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 867919 |
| Manufacturer | LSL INDUSTRIES, INC |
| Manufacturer Address | CHICAGO IL 60640 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-30 |