FDA Adverse Event
Summary report: N
MAUCH PLUS
MDR report key: 5380326
·
Received January 20, 2016
Report
- Report Number
- 1836248-2016-00001
- Date Received
- January 20, 2016
- Report Date
- October 4, 2016
- Manufacturer
- OSSUR AMERICAS, INC.
- Product Code
- ISY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE RETURNED FOR REPAIR AND ANALYSIS. REPORT WILL BE UPDATED WITH ANALYSIS RESULTS.
Description of Event or Problem · 1
AMPUTEE PATIENT WEARING PROSTHETIC KNEE, MAUCH PLUS, CLAIMS THE KNEE HAS POOR STANCE PHASE HYDRAULIC RESISTANCE. PATIENT CLAIMS TO HAVE FALLEN DOWN THE STAIRS WHILE USING THE PRODUCT.
Description of Event or Problem · 1
AMPUTEE PATIENT WEARING PROSTHETIC KNEE, MAUCH PLUS, CLAIMS THE KNEE HAS POOR STANCE PHASE HYDRAULIC RESISTANCE. PATIENT CLAIMS TO HAVE FALLEN DOWN THE STAIRS WHILE USING THE PRODUCT. NO INJURY OCCURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37441 | MAUCH PLUS | JOINT, KNEE, EXTERNAL LIMB COMPONENT | ISY | OSSUR AMERICAS, INC. | MKN71660 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |