FDA.reportPublic FDA data

MAUDE MDR 6802397

MDR report key
6802397
Report number
3012316249-2017-00100
Event key
0
Event type
3
Date of event
2017-07-07
Date received
2017-08-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THERMIPAQHOT/COLD PAIN RELIEF WRAPTOPS MEDICAL ARTICLES INDUSTRIESIMETPF5201LP* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-1701. O

Event Narratives#

D

Patient 1

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.