FDA Adverse Event
Injury
Summary report: N
MUELLER TENNIS ELBOW SUPPORT, MODERATE
MDR report key: 935309
·
Received October 28, 2007
Report
- Report Number
- MW5004196
- Event Type
- Injury
- Date Received
- October 28, 2007
- Date of Event
- October 10, 2007
- Report Date
- October 28, 2007
- Manufacturer
- MULLER SPORTS MEDICINE, INC.
- Product Code
- IQI
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NC
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I HAD THE MULLER TENNIS ELBOW SUPPORT WITH GEL PAD ON MY ARM FOR ONE HOUR AND DEVELOPED BLISTERS ON THE CONTACT POINTS FROM THE PAD. I STILL HAD THE BLISTERS AFTER ONE WEEK. DATES OF USE: 2007. EVENT ABATED AFTER USE STOPPED: YES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MUELLER TENNIS ELBOW SUPPORT, MODERATE | NONE | IQI | MULLER SPORTS MEDICINE, INC. | 6341 | 6341 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |