FDA Adverse Event
Injury
Summary report: N
FASCIADERM
MDR report key: 5366370
·
Received January 6, 2016
Report
- Report Number
- 2110420-2015-00003
- Event Type
- Injury
- Date Received
- January 6, 2016
- Date of Event
- February 4, 2015
- Report Date
- January 5, 2016
- Manufacturer
- MUELLER SPORTS MEDICINE, INC.
- Product Code
- FQM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
GOOD FAITH EFFORTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. MUELLER WILL SEND FOLLOW UP REPORT IF ADDITIONAL INPUT IS RECEIVED. THIS ISSUE WILL BE MONITORED THROUGH THE COMPLAINTS AND CAPA SYSTEM WITHIN MUELLER'S QUALITY MANAGEMENT SYSTEM. CLASSIFICATION : CLASS I EXEMPT.
Description of Event or Problem · 1
MUELLER SPORTS MEDICINE HAS REPORTED THIS COMPLAINT VOLUNTARILY BASED ON THE ISSUE OF POTENTIAL SERIOUS INJURY THAT COULD HAVE BEEN THE RESULT OF THE PRODUCT COMING IN CONTACT WITH CONSUMERS SKIN CAUSING A SKIN REACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9052 | FASCIADERM | PLANTAR FASCILITIS PAIN RELIEF SYSTEM | FQM | MUELLER SPORTS MEDICINE, INC. | 6337 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |