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 2019-03-13 for GENIUM 3B1-3 manufactured by Otto Bock Healthcare Products Gmbh.
[138647578]
Evaluation and investigation of the device showed no relevant error which may have caused or contributed to the occurred event.
Patient Sequence No: 1, Text Type: N, H10
[138647579]
The patient has slipped on ice with his healthy foot. The joint has no visible defect, now it should be checked if it is functional. Due to the fall an eruption from the shaft approach. The patient has slipped with the contralateral side when clearing snow, has supported himself with the prosthesis, went to the flexion stop and then the rupture of the shaft connection happened. The air in the hydraulics was already noticeable before the event. The patient got stuck with the contralateral side and then fell on the prosthesis!
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615892-2019-00005 |
| MDR Report Key | 8416044 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-02-04 |
| Date Mfgr Received | 2019-02-12 |
| Device Manufacturer Date | 2018-11-28 |
| Date Added to Maude | 2019-03-13 |
| 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, 1110 |
| Manufacturer Country | AU |
| Manufacturer Postal | 1110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENIUM |
| Generic Name | EXTERNAL ABOVE KNEE PROSTHESIS |
| Product Code | ISY |
| Date Received | 2019-03-13 |
| Returned To Mfg | 2019-02-18 |
| Model Number | 3B1-3 |
| Catalog Number | 3B1-3 |
| 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 | 2019-03-13 |