FDA.reportPublic FDA data

MAUDE MDR 7434608

MDR report key
7434608
Report number
0001831750-2018-00201
Event key
0
Event type
3
Date of event
2018-03-19
Date received
2018-04-16
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. MARY KLAVER
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
1UNKNOWN_MEDICAL_PRODUCTBED, FLOTATION THERAPY, POWEREDSTRYKER MEDICAL-KALAMAZOOIOQUNK_MEDN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-160

Event Narratives#

N

Patient 1

THE ACCOUNT COULD NOT PROVIDE THE SERIAL NUMBER OF THE SURFACE AS THEY HAD ONLY RECORDED THE SERIAL NUMBER OF THE BED AT THE TIME OF THE REPORTED EVENT. HOWEVER, NO PRODUCT MALFUNCTION IS ALLEGED. THE SERIAL NUMBER OF THE MATTRESS WAS NOT RECORDED.

D

Patient 1

IT WAS REPORTED THE PATIENT DEVELOPED A DEEP TISSUE INJURY WHILE ON THE MATTRESS. THE PATIENT HAD PREVIOUSLY BEEN FOUND AT THEIR HOME, UNCONSCIOUS ON THEIR COUCH FOR AN UNKNOWN AMOUNT OF TIME. THE PRESSURE INJURY ALLEGED DEVELOPED SHORTLY AFTER ADMISSION, AND THE DIRECTOR OF THE ICU REPORTED THEY DO NOT BELIEVE THE STRYKER MATTRESS CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT. THE PATIENT WAS TREATED WITH A SILICONE BANDAGE.