MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-27 for #11 SAFETY SCALPEL D4511A manufactured by S & S Surgical.
[89572091]
Investigation is still ongoing. Will provide follow up when more information is received.
Patient Sequence No: 1, Text Type: N, H10
[89572092]
********************************* >> quality issue information << ********************************* ----------------------- *** product details *** ----------------------- product id: d4511a - #11 safety scalpel, ns, #11 new design, bulk, ns. Lot/serial #: (b)(4). Quantity: 3 ea. Deroyal sales order #: 4156349. ----------------------------- *** 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? Not applicable. 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: scalpels were unlocked with blade engaged and exposed. Pictures provided. How was the quality issue was identified? By visual inspection. How was the product being used? N/a. 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: none. Person(s) affected by outcome(s) checked above: none. 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: n/a.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320762-2017-00011 |
| MDR Report Key | 6898772 |
| Date Received | 2017-09-27 |
| Date of Report | 2017-09-27 |
| Date of Event | 2017-08-28 |
| Date Mfgr Received | 2017-08-28 |
| 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 | 1595 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 | 0 |
| Brand Name | #11 SAFETY SCALPEL |
| Generic Name | HANDLE, SCALPEL |
| Product Code | GDZ |
| Date Received | 2017-09-27 |
| Model Number | D4511A |
| Lot Number | 44421536 |
| 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 | 2017-09-27 |