MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-05-15 for OTTO BOCK AXTION? PROSTHETIC FOOT 1E56 1E56=N28-4-P/0 manufactured by Otto Bock Healthcare Lp.
[75188809]
Patient Sequence No: 1, Text Type: N, H10
[75188810]
The customer reported the end-user was walking when the pyramid adapter on their axtion foot cracked. The pyramid failure caused the end-user to become detached from their foot which resulted in a fall. The fall caused minor pain in the hand and shoulder for the end-user. Outpatient medical care was sought, but no further medical attention was required or reported by the end-user. Based on purchase date of this axtion foot, it is very likely the foot was at or very near its intended life per iso 10328 testing. Although this specific occurrence did not result in permanent impairment for the end-user, the confirmed pyramid failure is known to have the potential to cause serious injury and therefore will be reported out of an abundance of caution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721652-2017-00005 |
| MDR Report Key | 6567674 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-05-15 |
| Date of Report | 2017-05-15 |
| Date of Event | 2017-04-20 |
| Date Mfgr Received | 2017-04-20 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2017-05-15 |
| 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 | 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 | 2017-05-15 |
| Returned To Mfg | 2017-05-08 |
| Model Number | 1E56 |
| Catalog Number | 1E56=N28-4-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 | 2017-05-15 |