MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-14 for OTTO BOCK AXTION? PROSTHETIC FOOT 1E56 1E56=N27-3-P/0 manufactured by Otto Bock Healthcare Lp.
[127361958]
It was discovered on 11/13/2018 that the original submission was not accepted due use of an incorrect icsr version. Icsr r2 is now required. I re-installed esubmitter in hopes the problem is resolved and my submission will be accepted. The cdrh emdr help desk suggested the re-installing of the esubmitter would resolve this issue. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[127361959]
Multiple attempts to seek information regarding the specific event(s) surrounding this failure were unsuccessful. Regardless of these attempts, a fall or injury was never reported or confirmed as this complaint was being handled. The customer reported information that the foot was being used within indications. Weight, activity level, and normal activities (walking on "road, path, meadow at home") reported were all well within this foot's intended use. This failure occurred within the intended use-life for this foot. Out of an abundance of caution, this complaint is being reported as an mdr since this confirmed device failure has demonstrated the risk of causing serious injury to the end-user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721653-2018-00002 |
| MDR Report Key | 8071245 |
| Date Received | 2018-11-14 |
| Date of Report | 2018-09-13 |
| Date of Event | 2018-08-20 |
| Date Mfgr Received | 2018-08-20 |
| Device Manufacturer Date | 2016-07-18 |
| Date Added to Maude | 2018-11-14 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OTTO BOCK AXTION? PROSTHETIC FOOT |
| Generic Name | 1E56 AXTION? PROSTHETIC FOOT |
| Product Code | ISH |
| Date Received | 2018-11-14 |
| Returned To Mfg | 2018-08-27 |
| Model Number | 1E56 |
| Catalog Number | 1E56=N27-3-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 | 2018-11-14 |