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 2020-02-13 for GENIUM X3 3B5-2 manufactured by Otto Bock Healthcare Products Gmbh.
[188689818]
Evaluation and investigation of the device showed no relevant error which may have caused or contributed to the occurred event (fall as well as change of resistance behavior).
Patient Sequence No: 1, Text Type: N, H10
[188689819]
Air in hydraulics, pt. States that walking feels different. Change of resistance behaviour: patient feels insecure. Patient fell and fractured her wrist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615892-2020-00001 |
| MDR Report Key | 9706154 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-02-13 |
| Date of Report | 2019-12-12 |
| Date of Event | 2019-11-23 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2017-05-10 |
| Date Added to Maude | 2020-02-13 |
| 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 | GENIUM X3 |
| Product Code | ISY |
| Date Received | 2020-02-13 |
| Model Number | 3B5-2 |
| Catalog Number | 3B5-2 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| 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 | 2020-02-13 |