MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-04 for FREE WALK 170K1 170K1=R-80-OBA-7 manufactured by Ottobock Se & Co Kgaa.
[188111622]
Due to our evaluation we assume that the failure of the product was related to the conditions the patient uses its device. The environmental surroundings (forest, wood logs, uneven ground, excessive usage of the product (5-7miles/day) might have also increased the wear of the product. Our evaluation shows that the product was in accordance to its specifications.
Patient Sequence No: 1, Text Type: N, H10
[188111623]
We received an orthosis from the patient showing a broken foot bar, right below the orthotic ankle joint. We assume that patient stumbled what resulted in a fall. Due to the fall the patient broke three ribs. The patient is homeless by choice and lives outside in the woods. He walks with the orthosis 4-7 miles/day on uneven terrain, hills and fallen logs. Patient find his orthosis extremely useful until it breaks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616494-2019-00001 |
| MDR Report Key | 9784821 |
| Date Received | 2020-03-04 |
| Date of Report | 2019-11-15 |
| Date of Event | 2019-10-15 |
| Date Mfgr Received | 2019-10-15 |
| Date Added to Maude | 2020-03-04 |
| 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. DOMINIK SCHMIDT |
| Manufacturer Street | MAX-NAEDER-STR. 15 |
| Manufacturer City | DUDERSTADT, 37115 |
| Manufacturer Country | GM |
| Manufacturer Postal | 37115 |
| Manufacturer G1 | OTTOBOCK SE & CO KGAA |
| Manufacturer Street | MAX-NAEDER-STR. 15 |
| Manufacturer City | DUDERSTADT, 37115 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 37115 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREE WALK |
| Generic Name | 170K1 |
| Product Code | ITQ |
| Date Received | 2020-03-04 |
| Returned To Mfg | 2019-10-21 |
| Model Number | 170K1 |
| Catalog Number | 170K1=R-80-OBA-7 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTTOBOCK SE & CO KGAA |
| Manufacturer Address | MAX-NAEDER-STR. 15 DUDERSTADT, 37115 GM 37115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-04 |