MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-05 for BARD-PARKER SAFETY SCALPEL SIZE 15, STERILE 372615 manufactured by Aspen Surgical Products, Caledonia.
[72114310]
Patient Sequence No: 1, Text Type: N, H10
[72114311]
The safety shield did not stay in place on the blade. The blade was coming out of the packaging. The device was not in use. The staff was poked with the blade. Minor injury was reported
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2017-00029 |
| MDR Report Key | 6461075 |
| Date Received | 2017-04-05 |
| Date of Report | 2017-03-10 |
| Date of Event | 2017-03-04 |
| Date Mfgr Received | 2017-03-10 |
| Date Added to Maude | 2017-04-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR BRADLEY LISKE |
| Manufacturer Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal | 49316 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BARD-PARKER SAFETY SCALPEL SIZE 15, STERILE |
| Generic Name | SCALPEL |
| Product Code | GDX |
| Date Received | 2017-04-05 |
| Model Number | 372615 |
| Lot Number | 0119616 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, CALEDONIA |
| Manufacturer Address | 6945 SOUTHBELT DR. S.E. CALEDONIA MI 49316 US 49316 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-05 |