MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-05-20 for SIMPLICITY 3 BLUE COVER LOCKING LINER 6Y521=290-5 manufactured by Otto Bock Healthcare Lp.
[5852525]
Patient fell, was injured by fall and taken by ambulance to hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721652-2015-00001 |
| MDR Report Key | 4786335 |
| Report Source | 01,05 |
| Date Received | 2015-05-20 |
| Date of Report | 2015-05-20 |
| Date Mfgr Received | 2015-12-17 |
| Device Manufacturer Date | 2014-01-10 |
| Date Added to Maude | 2015-05-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. CALEB BECK |
| Manufacturer Street | 3820 WEST GREAT LAKES DRIVE |
| Manufacturer City | SALT LAKE CITY UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal | 84120 |
| Manufacturer Phone | 8019746647 |
| Manufacturer G1 | OTTO BOCK HEALTHCARE LP |
| Manufacturer Street | 3820 WEST GREAT LAKES DRIVE |
| Manufacturer City | SALT LAKE CITY UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84120 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMPLICITY 3 BLUE COVER LOCKING LINER |
| Generic Name | LINER |
| Product Code | ISS |
| Date Received | 2015-05-20 |
| Returned To Mfg | 2015-02-13 |
| Model Number | 6Y521=290-5 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTTO BOCK HEALTHCARE LP |
| Manufacturer Address | 3820 WEST GREAT LAKES DRIVE SALT LAKE CITY UT 84120 US 84120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-05-20 |