MAUDE MDR 8613538

MDR report key
8613538
Report number
0001831750-2019-00566
Event key
0
Event type
3
Date of event
2019-03-03
Date received
2019-05-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. BRIAN THOMPSON
Address
3800 EAST CENTRE AVENUE PORTAGE MI 49002 US
Phone
269-269-2693
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CAPITAL TEMP PUMP PROFESSIONALPACK, HOT OR COLD, WATER CIRCULATINGSTRYKER MEDICAL-KALAMAZOOILOTP700Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-150

Event Narratives#

N

Patient 1

THE PATIENT CONDITION PRIOR TO THE ALLEGED INCIDENT WAS NOT DISCLOSED, HOWEVER, IT WAS IDENTIFIED THAT THERE WERE NO PRE-EXISTING CONDITIONS THAT WOULD HAVE MADE THE PATIENT SUSCEPTIBLE TO BURNS. THE PATIENT WAS IMMOBILE DURING HER STAY AT THE HOSPITAL AND HAD TO HAVE ASSISTANCE FOR ALL MEALS AND MOVEMENT. THE PATIENT HAD ALLEGED SHOULDER PAIN PRIOR TO USE OF THE T-PUMP AND A PHYSICIAN ORDERED HEAT THERAPY TO BE APPLIED BUT DID NOT INDICATE THE PARAMETERS OF USE. THE T-PUMP WAS USED WITH A MUL-T-PAD. THE MODEL AND LOT OF THE MUL-T-PAD WERE NOT RECORDED AT THE TIME OF THE EVENT. THE T-PUMP WAS ALLEGED TO BE SET AT 100 DEGREES F (38 DEGREES C) AND WAS USED CONTINUOUSLY WITH A 20 MINUTE CYCLE FOR THE NIGHT. THE PATIENT WAS PUT TO BED BETWEEN 17:30-18:30 ON MARCH 2ND AND WAS THEN WOKEN AT 7:25 ON MARCH 3RD. THERE WERE NO CHECKS OF THE PATIENTS SKIN RECORDED DURING THE TIME SHE WAS PUT TO BED AND THE TIME SHE WAS AWOKEN. THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH A BURN WOUND THAT WAS RINSED WITH STERILE SALINE AND HAD A FOAM DRESSING APPLIED. THE WOUND WAS NOTED TO BE CLOSED AND HEALED ON MARCH 19TH. INFORMATION WAS PROVIDED TO THE USER FACILITY THAT THE PATIENT'S SKIN SHOULD BE CHECKED REGULARLY TO ENSURE THE CONDITION IS APPROPRIATE TO CONTINUE THERAPY.

D

Patient 1

A PATIENT HAD SUPERFICIAL BURNS TO HER BACK AND PARTIAL THICKNESS BURNS TO (2) AREAS WITH THE WORST OVER THE LEFT SCAPULA. THE PATIENT HAD WOUND CARE PROVIDED FOLLOWING THE EVENT CONSISTING OF XEROFOAM TO BLISTERS WITH AN OPTIFOAM GENTLE DRESSING.