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 2019-03-11 for KENEVO 3C60 manufactured by Otto Bock Healthcare Products Gmbh.
[138358636]
Device is not available for evaluation (not returned from the customer yet); supplemental report will be submitted after additional information has been obtained.
Patient Sequence No: 1, Text Type: N, H10
[138358637]
The kenevo came back 01. 03 in ob (b)(4) with no previous notice. Patient fell on (b)(6) going down the stairs at home; he had been equipped for 3 weeks with the kenevo (2 weeks in b+ and one in c). The knee didn't lock and the patient mentions "it was like putting my foot in a hole". Patient went to (b)(6) hospital for xrays and skin care. Body damages : brachial and costal hematomas and light wounds on arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615892-2019-00004 |
| MDR Report Key | 8407023 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-03-11 |
| Date of Report | 2019-06-03 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-05-06 |
| Device Manufacturer Date | 2018-12-20 |
| Date Added to Maude | 2019-03-11 |
| 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 | KENEVO |
| Generic Name | EXTERNAL ABOVE KNEE PROSTHESIS |
| Product Code | ISY |
| Date Received | 2019-03-11 |
| Model Number | 3C60 |
| Catalog Number | 3C60 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-03-11 |