MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-03-20 for BLADE KNIFE manufactured by Ruettgers Surgicals P. Ltd..
[21606232]
The present packaging of this blade makes it almost impossible to present it to the surgical field in a sterile fashion. It takes numerous attempts to get one knife blade opened and four to five blades are usually wasted at one time. The way the packages are opened presents a hazard to the pt as an infection control issue and a hazard to the nursing staff because of the increased possibility of being stuck or cut by the blade.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001129 |
| MDR Report Key | 31405 |
| Date Received | 1996-03-20 |
| Date of Report | 1995-11-16 |
| Date Added to Maude | 1996-03-27 |
| 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 | 0 |
| 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 | BLADE KNIFE |
| Generic Name | BLADE KNIFE NO 15 |
| Product Code | EMF |
| Date Received | 1996-03-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 32524 |
| Manufacturer | RUETTGERS SURGICALS P. LTD. |
| Manufacturer Address | BOMBAY * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-03-20 |