MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-09-27 for SAFETYSCALPEL ASMB #3 FITMENT, #11 BLADE, BLUE NS SM4511NS manufactured by S & S Surgical.
[89468333]
Investigation is still ongoing. Will provide follow up when more information is received.
Patient Sequence No: 1, Text Type: N, H10
[89468334]
>> quality issue information << *** product details *** product id: sm4511ns - safety scalpel asmbd #3 fitment, #11 blade, blue ns. Lot/serial #: (b)(4). Quantity: 1 ea. Deroyal sales order (b)(4). *** quality issue details *** date of occurrence: (b)(6) 2017. When did quality issue occur? Before use. Who was using or operating the product when the quality issue occurred? Other. Was a medical procedure involved? No. Name of medical procedure: not applicable. Did the quality issue cause a delay in the medical procedure? Not applicable. Detailed description of quality issue: during unpacking an operator was injured by a protruding blade. How was the quality issue was identified? By visual inspection. How was the product being used? During unpacking and inspection. Was it the initial use of the product? No. Was the product modified from the original condition supplied by deroyal? No. Was the product connected to or used in conjunction with other devices or equipment? No. *** outcome details *** outcome(s) attributed to quality issue: required medical attention to prevent impairment. Details of medical attention required to prevent impairment: unpacking operator was cut by blade during unpacking. Person(s) affected by outcome(s) checked above: facility employee. Known pre-existing condition(s) of person(s) affected: none specified. Was the incident reported to the fda? No. Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: injury caused to operative during unpacking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2017-00017 |
| MDR Report Key | 6898761 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-09-27 |
| Date of Report | 2017-08-28 |
| Date of Event | 2017-08-24 |
| Date Mfgr Received | 2017-08-20 |
| Date Added to Maude | 2017-09-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1703 HWY 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 | SAFETYSCALPEL ASMB #3 FITMENT, #11 BLADE, BLUE NS |
| Generic Name | HANDLE, SCALPEL |
| Product Code | GDZ |
| Date Received | 2017-09-27 |
| Model Number | SM4511NS |
| Lot Number | 012072 |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2017-09-27 |