MUELLER ADJUSTABLE ANKLE SUPPORT

Additional Manufacturer Narrative

(B)(4 ): 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. NUMBEROUS ATTEMPTS WERE MADE TO GATHER MORE INFORMATION FROM CONSUMER WITHOUT ANY SUCCESS. THIS ISSUE WILL BE MONITORED THROUGH THE COMPLAINTS AND CAPA SYSTEM WITHIN MUELLER'S QUALITY MANAGEMENT SYSTEM. COMPLAINT HAS BEEN CLOSED WITH NO FURTHER ACTION OR INVESTIGATION AT THIS TIME. CLASSIFICATION: CLASS I EXEMPT.

Description of Event or Problem

CUSTOMER BOUGHT PRODUCT FROM (B)(6) BECAUSE THE CARTON SAID LATEX FREE MATERIALS. SHE WORE IT FOR 2 DAYS AND HAD AN EXTREME REACTION THAT IS SIMILAR TO THE ONE THAT SHE GETS FROM LATEX. NUMEROUS ATTEMPTS TO CONTACT CONSUMER DID NOT PRODUCE ADDITIONAL INFORMATION.