MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-05-22 for OTTO BOCK AXTION? PROSTHETIC FOOT 1E56 1E56=N28-5-P/0 manufactured by Otto Bock Healthcare Lp.
[109376351]
Patient Sequence No: 1, Text Type: N, H10
[109376352]
The end-user reported he was performing normal household duties when the pyramid failure occurred on his axtion foot. No fall or injury occurred with respect to this specific reported pyramid failure. The end-user's foot remained within the intended use-life of the product and the foot was being used within the designated indications. Out of an abundance of caution, this complaint will be reported as an mdr since this confirmed device failure is known to have the potential to cause serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721652-2018-00001 |
| MDR Report Key | 7534224 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-22 |
| Date of Event | 2018-04-26 |
| Date Mfgr Received | 2018-04-26 |
| Device Manufacturer Date | 2016-07-18 |
| Date Added to Maude | 2018-05-22 |
| 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 | MR. STEPHEN ANDERSON |
| Manufacturer Street | 3820 WEST GREAT LAKES DRIVE |
| Manufacturer City | WEST VALLEY CITY UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal | 84120 |
| Manufacturer Phone | 8019746676 |
| Manufacturer G1 | OTTO BOCK HEALTHCARE LP |
| Manufacturer Street | 3820 WEST GREAT LAKES DRIVE |
| Manufacturer City | WEST VALLEY 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 | OTTO BOCK AXTION? PROSTHETIC FOOT |
| Generic Name | 1E56 AXTION? PROSTHETIC FOOT |
| Product Code | ISH |
| Date Received | 2018-05-22 |
| Returned To Mfg | 2018-05-21 |
| Model Number | 1E56 |
| Catalog Number | 1E56=N28-5-P/0 |
| 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 WEST VALLEY CITY UT 84120 US 84120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-22 |