MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-03-29 for SAFETY SCALPEL SM4511NS manufactured by S & S Surgical.
[140316611]
Investigation summary: an internal complaint (call (b)(4)) was received indicated that a safety scalpel (part number sm4511ns, lot 012645) was not fully retracted during inspection. A blade was exposed thus creating a safety hazard. The defective device was not available for return. However, photos were provided that confirm the reported event. The investigation is ongoing at this time. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[140316612]
The blades of safety scalpels were found sticking out during inspection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2019-00005 |
| MDR Report Key | 8464721 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-03-29 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-02-26 |
| Date Mfgr Received | 2019-02-27 |
| Date Added to Maude | 2019-03-29 |
| 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 | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1703 HIGHWAY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFETY SCALPEL |
| Generic Name | HANDLE, SCALPEL |
| Product Code | GDZ |
| Date Received | 2019-03-29 |
| Model Number | SM4511NS |
| Lot Number | 012645 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | S & S SURGICAL |
| Manufacturer Address | 117 EDGINGTON LANE WHEELING WV 26003 US 26003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-29 |