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 2019-05-14 for C-LEG 3C98-3 manufactured by Otto Bock Healthcare Products Gmbh.
[144941000]
Device evaluation in progress; supplemental report will be submitted after additional information has been obtained.
Patient Sequence No: 1, Text Type: N, H10
[144941001]
Not holding a charge. Buckling up when standing. Chirping when plugged in. Patient fell several times on the device, once where he badly injured his hip and needed hospitalization. Date of that fall is unknown but it was prior to (b)(6) 2018. The knee was sent in for service by amputee clinic but they did not report any fall to ottobock when the device was sent in. Patient was fit with a loaner by that practitioner and he reports that he did not have any issues with the loaner device. Ottobock completed the evaluation on (b)(6) 2019 but were unable to find any mechanical issues with the knee. While his knee was in for service the patient made the decision to stop going to amputee clinic and started going to hanger clinic. Device was sent back to (b)(4). Patient reports that the (b)(4) facility told him he had to give back the loaner even though he did not feel safe on his knee. He said that they refit him with his knee and he has already fallen once since then, he said he has had the knee back for a few days now. He didnt report any injuries with the recent fall. The practitioner stated that the falling was due to an alignment issue, not anything wrong with the c-leg. The practitioner has talked to the pt and worked with him on his walking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615892-2019-00007 |
| MDR Report Key | 8606762 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-05-14 |
| Date of Report | 2019-06-14 |
| Date Mfgr Received | 2019-05-15 |
| Device Manufacturer Date | 2018-05-23 |
| Date Added to Maude | 2019-05-14 |
| 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 | C-LEG |
| Generic Name | EXTERNAL ABOVE KNEE PROSTHESIS |
| Product Code | ISY |
| Date Received | 2019-05-14 |
| Returned To Mfg | 2019-04-25 |
| Model Number | 3C98-3 |
| Catalog Number | 3C98-3 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 | BREHMSTRASSE 16 VIENNA, 1110 AU 1110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-05-14 |