FASCIADERM

Additional Manufacturer Narrative

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

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.