MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-11-08 for WEIGHTED SAFETY SCALPEL 2210-N manufactured by Ansell Sandel Medical Solutions Llc.
[16218230]
Blade protruded through packaging (package was not open). Safety guard on scalpel was not covering blade. Nurse was taking scalpel from bin and blade struck her thumb.
Patient Sequence No: 1, Text Type: D, B5
[16577993]
No medical intervention was required. Cut finger was cleaned, band aid applied. The incident device was returned. A follow up report will be provided upon completion of investigation. In accordance with 21 cfr 803. 56, if we obtain additional info which was not known or was not available when the initial report was submitted, a supplemental report will be submitted to fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004125670-2013-00001 |
| MDR Report Key | 3487588 |
| Report Source | 08 |
| Date Received | 2013-11-08 |
| Date of Report | 2013-11-11 |
| Date of Event | 2013-10-11 |
| Date Mfgr Received | 2013-10-16 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2013-12-27 |
| 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 |
| Remedial Action | RC |
| 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 | 2013-11-08 |
| Returned To Mfg | 2013-11-05 |
| Catalog Number | 2210-N |
| Lot Number | 0563 |
| Device Expiration Date | 2016-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2013-11-08 |