MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-15 for DEROYAL STERILE NO.11 DISPOSABLE SCALPEL 6503 manufactured by Swann Morton, Ltd.
[62476518]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[62476519]
No. 11 deroyal sterile disposable scalpel protruded through its packaging and had caused the end user to cut herself.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611194-2016-00001 |
| MDR Report Key | 6177058 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-15 |
| Date of Report | 2016-10-20 |
| Date Mfgr Received | 2016-10-07 |
| Device Manufacturer Date | 2016-03-10 |
| Date Added to Maude | 2016-12-15 |
| 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 | KEVIN WALLS |
| Manufacturer Street | 33 GOLDEN EAGLE LANE |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal | 80127 |
| Manufacturer Phone | 7209625412 |
| Manufacturer G1 | SWANN MORTON, LTD |
| Manufacturer Street | OWLERTON GREEN |
| Manufacturer City | SHEFFIELD, |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL STERILE NO.11 DISPOSABLE SCALPEL |
| Generic Name | SCALPEL |
| Product Code | GDX |
| Date Received | 2016-12-15 |
| Model Number | 6503 |
| Lot Number | 6591603 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SWANN MORTON, LTD |
| Manufacturer Address | OWLERTON GREEN SHEFFIELD, UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-15 |