inforMED
InjuryIME

THERMIPAQ

Received Aug 17, 2017 · Event occurred Jul 7, 2017

Report 3012316249-2017-00100 · MDR key 6802397

Device

Generic name

Hot/cold Pain Relief Wrap

Model number

TPF5201LP

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

57 YR

  • Partial thickness (Second Degree) Burn
  • Partial thickness (Second Degree) Burn

Narrative

Description of Event or Problem

THE USER HAD THIS DEVICE IN THE FREEZER FOR AN HOUR, AND PUT IT OVER AN ELASTIC BANDAGE THAT WAS WRAPPED AROUND HER ANKLE AND TOP OF FOOT. THE USER THEN FELL ASLEEP, WOKE UP, AND TOOK THE DEVICE OFF. THE ELASTIC BANDAGE WAS WET IN A COUPLE OF SPOTS. THE BANDAGE WAS UNWRAPPED, AND THE USER IMMEDIATELY HAD LARGE BLISTERS. THE USER USED AN ANTIBIOTIC LIP TREATMENT BY ACCIDENT, AND WHEN SHE WIPED IT OFF, HER SKIN CAME OFF. THE USER WENT TO THE DOCTOR'S, AND THE DOCTOR SAID SHE HAD SECOND DEGREE BURNS. THE USER WAS PRESCRIBED ANTIBIOTICS, AND PUT A CREAM AND NEW DRESSING ON HER INJURIES EVERY DAY, BUT ALSO HAS AN IN-HOME CARE SPECIALIST COME OUT THAT CHANGES IT TWICE A WEEK.