MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-30 for SWANN MORTON 0291 manufactured by Swann-morton Ltd.
[146933755]
Surgical blade snapped in half in patient's shoulder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611194-2019-00004 |
| MDR Report Key | 8656527 |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-23 |
| Date of Event | 2019-05-17 |
| Date Mfgr Received | 2019-05-22 |
| Date Added to Maude | 2019-05-30 |
| 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 | PENN WORKS OWLERTON GREEN |
| Manufacturer City | SHEFFIELD, |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SWANN MORTON |
| Generic Name | SCALPEL BLADE |
| Product Code | GES |
| Date Received | 2019-05-30 |
| Model Number | 0291 |
| Catalog Number | 0291 |
| Lot Number | 5081711 |
| 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 | PENN WORKS OWLERTON GREEN SHEFFIELD, UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-30 |