MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-01-29 for DEROYAL D4511A manufactured by S&s Surgical.
[3153098]
It was reported that a blade was sticking out from one of the bottom flaps of the box. When opened the employee contacted the blade and received a laceration requiring a trip to the hospital, 3 x-rays, a tetanus shot, and three stitches on her index finger.
Patient Sequence No: 1, Text Type: D, B5
[10375007]
Describe event or problem: it was reported that a blade was sticking out from one of the bottom flaps of the box. When opened the employee contacted the blade and received a laceration requiring a trip to the hospital, 3 x-rays, a tetanus shot, and three stitches on her index finger. Deroyal: pictures of the defect were received for our investigation. Internal inspections were performed during the relabeling process and on finished goods where no defects were found. As a corrective action all applicable personnel received retraining for heightened awareness when packaging this product to verify that the blades are not exposed. The product is under 100% inspection to verify all blades are retracted prior to packaging.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004605321-2013-00001 |
| MDR Report Key | 2939276 |
| Report Source | 06 |
| Date Received | 2013-01-29 |
| Date of Report | 2013-01-08 |
| Date of Event | 2013-01-08 |
| Date Facility Aware | 2013-01-08 |
| Report Date | 2013-01-08 |
| Date Reported to Mfgr | 2013-01-08 |
| Date Mfgr Received | 2013-01-08 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2013-02-04 |
| 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 | 0 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | GDZ - HANDLE, SCALPEL |
| Product Code | GDZ |
| Date Received | 2013-01-29 |
| Catalog Number | D4511A |
| Lot Number | 29888883 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | S&S SURGICAL |
| Manufacturer Address | TRIADELPHIA WV US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-01-29 |