MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-03-05 for DEROYAL D6205 manufactured by Swann Morton, Ltd..
[4244306]
The scalpel is cutting jagged, basically tearing a vein. The doctors have changed to another brand.
Patient Sequence No: 1, Text Type: D, B5
[11571884]
Deroyal: the investigation into the root cause is in process. The reported deice has not been returned at this time. There have been no similar complaints filed for this product line prior to this customer filing three reports on this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1060680-2014-00004 |
| MDR Report Key | 3674394 |
| Report Source | 08 |
| Date Received | 2014-03-05 |
| Date of Report | 2014-02-11 |
| Date of Event | 2014-02-10 |
| Date Facility Aware | 2014-02-10 |
| Report Date | 2014-02-11 |
| Date Reported to Mfgr | 2014-02-11 |
| Date Mfgr Received | 2014-02-11 |
| Date Added to Maude | 2014-03-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | COURTNEY RINEHART |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653622122 |
| Manufacturer G1 | DEROYAL SURGICAL FABRICATION |
| 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 | DEROYAL |
| Generic Name | SCALPEL, ONE PIECE |
| Product Code | GDX |
| Date Received | 2014-03-05 |
| Catalog Number | D6205 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SWANN MORTON, LTD. |
| Manufacturer Address | SHEFFIELD UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-05 |