MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-24 for MEDLINE MDS15411 * manufactured by Medline Industries, Inc..
[559366]
Surgeon almost injured self while attempting to use the #11 safety blade; 3 different blades tried, all malfunctioned. No pt harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1041709 |
| MDR Report Key | 808337 |
| Date Received | 2007-01-24 |
| Date of Report | 2007-01-16 |
| Date of Event | 2006-11-20 |
| Date Added to Maude | 2007-01-26 |
| 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 | MEDLINE |
| Generic Name | # SAFETY BLADE |
| Product Code | GDX |
| Date Received | 2007-01-24 |
| Model Number | MDS15411 |
| Catalog Number | * |
| Lot Number | 06GA0302 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 795822 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PL MUNDELEIN IL 60060 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-24 |