MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for SYMBIONIC LEG 3 SMBE5260 manufactured by ?ssur Hf.
[118559072]
The patient reported to have fallen while walking the stairs due to the knee, and indicated the electronics sometimes stop working without any reason. He is not injured. The product is currently at ossur quality center pending investigation. During the general quality check the leg did pass all the tests implying good functionality of the product. However, the error log showed that the electronic errors the user experienced during use indeed appeared, indicating malfunctioning of the leg might have contributed to the event. Issue at this moment seems to be a unique case. Issue will be further investigated to determine root cause and necessary actions. No initial corrective/preventive actions are considered warranted based on information currently available. There have been no similar incidents reported.
Patient Sequence No: 1, Text Type: N, H10
[118559073]
The patient reported to have fallen while walking the stairs due to the knee, and indicated the electronics sometimes stop working without any reason. He is not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2018-00002 |
| MDR Report Key | 7820748 |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-07-19 |
| Date Mfgr Received | 2018-07-16 |
| Date Added to Maude | 2018-08-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. CRYSTAL SWAFFORD |
| Manufacturer Street | 27051 TOWNE CENTRE DRIVE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493823817 |
| Manufacturer G1 | OSSUR HF |
| Manufacturer Street | GRJOTHALS 1-5 |
| Manufacturer City | REYKJAVIK, REYKJAVIK 110 |
| Manufacturer Country | IC |
| Manufacturer Postal Code | 110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYMBIONIC LEG 3 |
| Generic Name | SYMBIONIC LEG 3 |
| Product Code | ISW |
| Date Received | 2018-08-27 |
| Returned To Mfg | 2018-08-17 |
| Model Number | SMBE5260 |
| Catalog Number | SMBE5260 |
| Device Availability | R |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ?SSUR HF |
| Manufacturer Address | GRJOTHALS 1-5 REYKJAVIK, REYKJAVIK 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-27 |