MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-08-02 for LINER PROTECT 3C 28 MTRX 10 MC97128 manufactured by Ossur Bayreuth.
[81636990]
Product evaluation ongoing - will follow-up with a supplemental report to include product evaluation.
Patient Sequence No: 1, Text Type: N, H10
[81637031]
Below knee amputee patient was wearing a protect prosthetic liner and claims the pin came loose from the liner causing him to fall resulting in a broken foot on his sound side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006221031-2017-00001 |
| MDR Report Key | 6761286 |
| Report Source | FOREIGN |
| Date Received | 2017-08-02 |
| Date of Report | 2017-11-17 |
| Date Mfgr Received | 2017-07-06 |
| Date Added to Maude | 2017-08-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9492757557 |
| Manufacturer G1 | OSSUR BAYREUTH |
| Manufacturer Street | LOGISTIGPARK 7A |
| Manufacturer City | BAYREUTH 95448 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 95448 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINER PROTECT 3C 28 MTRX 10 |
| Generic Name | PROSTHETIC LINER |
| Product Code | ISS |
| Date Received | 2017-08-02 |
| Returned To Mfg | 2017-07-21 |
| Model Number | MC97128 |
| Catalog Number | MC97128 |
| 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 | OSSUR BAYREUTH |
| Manufacturer Address | LOGISTIGPARK 7A BAYREUTH 95448 GM 95448 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-02 |