MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-09 for BD SAFETY SCALPEL * manufactured by Cardinal Health.
[2351776]
The doctor was able to puncture the patient's skin; however, he was unable to cut. The doctor felt the scalpel blade was dull and requested another scalpel to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2344287 |
| MDR Report Key | 2344287 |
| Date Received | 2011-11-09 |
| Date of Report | 2011-11-09 |
| Date of Event | 2011-11-03 |
| Report Date | 2011-11-09 |
| Date Reported to FDA | 2011-11-09 |
| Date Added to Maude | 2011-11-21 |
| 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 | BD SAFETY SCALPEL |
| Generic Name | SAFETY SCALPEL #11 |
| Product Code | GDX |
| Date Received | 2011-11-09 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 068508 (CARDINAL LOT #) |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN RD. MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-09 |