FDA.reportPublic FDA data

MAUDE MDR 6854363

MDR report key
6854363
Report number
6854363
Event key
0
Event type
3
Date of event
2017-08-28
Date received
2017-09-11
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1POLAR CARE CUBEPACK, HOT OR COLD, WATER CIRCULATINGBREG, INCIME10701272180610R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-110

Event Narratives#

N

Patient 1

D

Patient 1

PATIENT A: POLAR CUBE WAS NOT WORKING FOR PATIENT SO THEY RETURNED IT TO HOSPITAL. PATIENT B: POLAR CUBE PUMP WAS RUNNING BUT NO COLD WATER WAS BEING PUSHED TO THE PAD ON THE PATIENT'S SHOULDER. WE REPLACED IT FOR A DIFFERENT ONE FOR PATIENT. MANUFACTURER RESPONSE FOR POLAR CARE CUBE, BREG POLAR CARE CUBE (PER SITE REPORTER). BREG REPRESENTATIVE CALLED TO ARRANGE A MAILER LABEL FOR RETURN OF DEVICES FOR TESTING AND WILL REPLACE.