MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-02-27 for GENIUM X3 3B5-3 manufactured by Otto Bock Healthcare Products Gmbh.
[188689947]
Evaluation and investigation of the device showed no relevant error which may have caused or contributed to the occurred event. According to the event description and in accordance with the results of the device investigation the user has been involved in an accident. Thus the device can be excluded to be the root cause which may have caused or contributed to the occurred event.
Patient Sequence No: 1, Text Type: N, H10
[188689948]
Please inspect and evaluate the knee units and pylons pt was in a significant motorcycle accident and need to ensure proper functionality on components. Knee was functioning before and that this was an externalforce causing the damage to the units and that it was not due to malfunction of the knee patient was the driver of the motor cycle. Patient did suffer significant injuries (multiple spinal, pelvic and rib fractures as well as a broken arm) and is still in the hospital doing pt and ot patient was driver of a motorcycle and was in an accident resulting in hospital stay as well as physical therapy. This patient is a bi-lat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615892-2020-00002 |
| MDR Report Key | 9763363 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-02-27 |
| Date of Report | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2019-06-26 |
| Date Added to Maude | 2020-02-27 |
| 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 | MR. REINHARD WOLKERSTORFER |
| Manufacturer Street | BREHMSTRASSE 16 |
| Manufacturer City | VIENNA, VIENNA 1110 |
| Manufacturer Country | AU |
| Manufacturer Postal | 1110 |
| Manufacturer G1 | OTTO BOCK HEALTHCARE PRODUCTS GMBH |
| Manufacturer Street | BREHMSTRASSE 16 |
| Manufacturer City | VIENNA, 1110 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 1110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENIUM X3 |
| Generic Name | EXTERNAL ABOVE KNEE PROSTHESIS |
| Product Code | ISY |
| Date Received | 2020-02-27 |
| Returned To Mfg | 2020-02-03 |
| Model Number | 3B5-3 |
| Catalog Number | 3B5-3 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTTO BOCK HEALTHCARE PRODUCTS GMBH |
| Manufacturer Address | BREHMSTRASSE 16 VIENNA, 1110 AU 1110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-02-27 |