ACE¿ DELUXE BACK STABILIZER W/ PAD

Additional Manufacturer Narrative

PRODUCT LOT # WAS NOT PROVIDED. THIS PRODUCT DOES NOT HAVE AN ESTABLISHED SHELF LIFE. INITIAL REPORTER'S OCCUPATION IS UNKNOWN. PRODUCT LOT # WAS NOT PROVIDED, THEREFORE DEVICE MANUFACTURE DATE IS UNKNOWN. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. PRODUCT LOT # WAS NOT PROVIDED. AT THIS TIME, THERE ARE INSUFFICIENT DETAILS TO INVESTIGATE AS NO PHOTOS OF THE PRODUCT WERE INCLUDED FOR PRODUCT CONFIRMATION, NOR WAS A PRODUCT LOT NUMBER PROVIDED. ROOT CAUSE COULD NOT BE ESTABLISHED. SOME CONSUMERS MAY HAVE SENSITIVITIES TO NEOPRENE. THE PRIMARY PACKAGING DOES CONTAIN A CAUTION STATEMENT FOR NEOPRENE. CAUTION: SOME INDIVIDUALS, MAY BE SENSITIVE TO NEOPRENE OR NEOPRENE-BLEND RUBBER. IF A RASH DEVELOPS, DISCONTINUE USE AND CONSULT A PHYSICIAN. COMPLAINT TRENDING WAS CONDUCTED FOR THE PAST 2 YEARS FOR PRODUCT FAMILY CODE, DSB. THIS APPEARS TO BE AN ISOLATED OCCURRENCE. 3M WILL CONTINUE TO MONITOR. END OF REPORT.

Description of Event or Problem

A FEMALE CONSUMER (AGE NOT SPECIFIED) WORE THE REFERENCED BACK STABILIZER DURING WORK ON (B)(6) 2019. THE STABILIZER WAS WORN FOR APPROXIMATELY 12 HOURS. THE CONSUMER ALLEGED SHE BROKE OUT IN RASH. THE RASH WAS DESCRIBED AS RED, ITCHY SPLOTCHES ON THE SKIN. THE CONSUMER REPORTED THE RASH GOT PROGRESSIVELY WORSE THE NEXT DAY. NO KNOWN ALLERGIES OR SKIN SENSITIVES WERE SPECIFIED. THE CONSUMER VISITED THE ER AND WAS PRESCRIBED FAMOTIDINE, BANOPHEN, AND PREDNISONE. FURTHER DETAILS REGARDING REPORTED INCIDENT WERE NOT PROVIDED.