MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-05-08 for GENIUM - BIONIC PROSTHETIC SYSTEM 3B1=S manufactured by Otto Bock Healthcare Products Gmbh.
[4500779]
No resistance of joint and patient fell. No injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615892-2014-00005 |
| MDR Report Key | 3830099 |
| Report Source | 08 |
| Date Received | 2014-05-08 |
| Date of Report | 2014-05-08 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-04-09 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2014-06-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | REINHARD WOLKERSTORFER |
| Manufacturer Street | KAISERSTRASSE 39 |
| Manufacturer City | VIENNA 1070 |
| Manufacturer Country | AU |
| Manufacturer Postal | 1070 |
| Manufacturer Phone | 5233786676 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENIUM - BIONIC PROSTHETIC SYSTEM |
| Generic Name | EXTERNAL ABOVE KNEE PROSTHESIS |
| Product Code | ISW |
| Date Received | 2014-05-08 |
| Model Number | 3B1=S |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTTO BOCK HEALTHCARE PRODUCTS GMBH |
| Manufacturer Address | VIENNA AU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-08 |