MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2014-01-13 for WEIGHTED SAFETY SCALPEL 2210-NSS manufactured by Ansell Sandel Medical Solutions Llc.
[4336030]
Reporter stated that after a surgical procedure was completed, a surgical tech was cleaning up the area when she had some difficulty closing the scalpel. Her glove became caught on the button that slides, causing her hand to slip. When this occurred, the tip of the blade stabbed her other hand. The surgical tech received first aid only since the surgery pt was low risk. Medical treatment was not necessary.
Patient Sequence No: 1, Text Type: D, B5
[11727520]
No medical intervention was required. Cut finger was cleaned, first aid applied only. Product is not being returned for eval. In accordance with 21 cfr 803. 56, if we obtain add'l info which was not known or was not available when the initial report will be submitted to fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004125670-2014-00001 |
| MDR Report Key | 3711319 |
| Report Source | 05,08 |
| Date Received | 2014-01-13 |
| Date of Report | 2013-12-16 |
| Date of Event | 2013-12-15 |
| Date Mfgr Received | 2013-12-17 |
| Date Added to Maude | 2014-04-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHELLEY ARNOLD |
| Manufacturer Street | 19736 DEARBORN STREET |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8185342500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WEIGHTED SAFETY SCALPEL |
| Generic Name | SAFETY SCALPEL |
| Product Code | GDX |
| Date Received | 2014-01-13 |
| Catalog Number | 2210-NSS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANSELL SANDEL MEDICAL SOLUTIONS LLC |
| Manufacturer Address | 19736 DEARBORN STREET CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-13 |