MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for FLEX-RUN WITH NIKE SOLE FSX0087LO manufactured by Ossur Hf.
[145529626]
No fall/incident nor injury occurred due to the reported failure. Given the intended use (running, sports activities) of the product, there is a risk for issue leading to injury when failure would occur during use. Therefore we send in this vigilance report. Ossur is however not aware that the described failure type for this prosthetic foot ever led to injury. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145529627]
Device broke suddenly during training. No injuries occured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2019-00007 |
| MDR Report Key | 8621621 |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-17 |
| Date Mfgr Received | 2019-04-17 |
| Date Added to Maude | 2019-05-17 |
| 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 | KATLA AXELSDOTTIR |
| Manufacturer Street | GRJOTHALS 1-5 |
| Manufacturer City | REYKJAVIK, 110 |
| Manufacturer Country | IC |
| Manufacturer Postal | 110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FLEX-RUN WITH NIKE SOLE |
| Generic Name | PROSTHETIC FOOT |
| Product Code | ISH |
| Date Received | 2019-05-17 |
| Returned To Mfg | 2019-04-24 |
| Model Number | FSX0087LO |
| Catalog Number | FSX0087LO |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR HF |
| Manufacturer Address | GRJOTHALS 1-5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-17 |