FDA.reportPublic FDA data

MAUDE MDR 7045823

MDR report key
7045823
Report number
3012316249-2017-00133
Event key
0
Event type
3
Date received
2017-11-20
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
1CAREXCOLD PACKTOPS MEDICAL ARTICLES INDUSTRIESIMETMF32411102* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-2001. O; 2. R

Event Narratives#

D

Patient 1

THE USER FELL AT WORK, AND SPRAINED HER KNEE - SHE HAD BEEN GOING TO PHYSICAL THERAPY, AND WHEN SHE IS DONE, THEY PUT AN ICE PACK ON HER. SHE WAS HOME, AND HER KNEE WAS SORE, AND SHE HAD AN ICE PACK THAT SHE BOUGHT HER SON LAST YEAR. SHE PUT IT ON, AND IT HURT, BUT SHE KEPT IT ON FOR 15 MINUTES. HER KNEE AFTER THAT TIME WAS VERY SORE, SWOLLEN, AND VERY RED. SHE PUT A BANDAGE ON IT AND WENT BACK TO WORK. HER BOSS SAW HER, AND HE CALLED HER IN TO LOOK AT HER KNEE, AND HE TOLD HER SHE NEEDED TO GO TO URGENT CARE. THE DOCTOR THERE TOLD HER SHE HAD SECOND DEGREE FROSTBITE, AND THEY GAVE HER A CREAM TO PUT ON.