MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-07-25 for SYMMETRY SURGICAL 01-2707 manufactured by Symmetry Surgical.
[3619067]
The blade on the scalpel blade did not fit properly on the handle, and the nurse cut her hand requiring stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2013-00005 |
| MDR Report Key | 3252077 |
| Report Source | 07 |
| Date Received | 2013-07-25 |
| Date of Report | 2013-07-25 |
| Date of Event | 2013-06-20 |
| Date Mfgr Received | 2013-06-27 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2013-07-30 |
| 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 Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 8002513000 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMMETRY SURGICAL |
| Generic Name | SCALPEL BLADE HOLDER |
| Product Code | HXK |
| Date Received | 2013-07-25 |
| Returned To Mfg | 2013-06-26 |
| Model Number | 01-2707 |
| Catalog Number | 01-2707 |
| Lot Number | 0313 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL |
| Manufacturer Address | 3034 OWEN DR ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-07-25 |