inforMED
InjuryIME

BED BUDDY

Received Aug 30, 2017

Report 3012316249-2017-00107 · MDR key 6830894

Device

Generic name

Hot & Cold Back Wrap

Model number

BBF5085-12

Catalog number

BBF5085-12

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Burn(s)
  • Burn(s)

Narrative

Description of Event or Problem

A USER RETURNED THE HOT & COLD BACK WRAP - THE USER COMPLAINED THAT IT HAD BURNED HER BACK. THE USER SHOWED THE STORE FLOOR LEADER THE BURNS, IN WHICH SHE TOOK PICTURES OF, AND LEFT IN THE STORE'S OFFICE, ALONG WITH THE PRODUCT. NO FURTHER RESPONSE WAS RECEIVED REGARDING THIS EVENT.