FDA Adverse Event
Injury
Summary report: N
MAUCH
MDR report key: 1689104
·
Received May 7, 2010
Report
- Report Number
- 1836248-2010-00004
- Event Type
- Injury
- Date Received
- May 7, 2010
- Date of Event
- April 4, 2010
- Report Date
- May 7, 2010
- Manufacturer
- OSSUR AMERICAS
- Product Code
- ISY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT WAS WALKING AND CYLINDER SHEARED OFF AT DISTAL END. PT FELL AS A RESULT INJURED SHOULDER. PT WENT TO THE DOCTOR, NO FURTHER INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAUCH | ISY | OSSUR AMERICAS | FRM01801U | 213791 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention |