MUELLER REVERSIBEL THUMB STABILIZER

Additional Manufacturer Narrative

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. 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

CONSUMER PURCHASED AT A (B)(6) AND HAD PRODUCT FOR APPROX 3 WEEKS. HE USED IT DAILY FROM 10PM TO 8 AM ACCORDING TO CONSUMER. HE HAD A REACTION AFTER WEARING THUMB STABILIZER AFTER ABOUT 3 TO 4 DAYS OF USE. HE STATED HE BROKE OUT IN A BAD RASH LOOKING LIKE POISON IVY OR OAK AND WENT TO A DR.