FDA.reportPublic FDA data

MAUDE MDR 9570295

MDR report key
9570295
Report number
1531186-2020-00001
Event key
0
Event type
3
Date received
2020-01-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALTERNATING PRESSURE MATTRESS W/LOW AIR LOSS, 36 X 80 X 10, 50L 9153647225MATTRESS, AIR FLOTATION, ALTERNATING PRESSUREKAP MEDICALFNMNA:MA65MA65R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-0901. R

Event Narratives#

N

Patient 1

THIS COMPLAINT IS BEING FILED IN AN ABUNDANCE OF CAUTION. THE DEALER ADVISED THE END-USER IS BED BOUND AND IS CURRENTLY STILL USING MATTRESS IN A PRIVATE HOME. TECHNICIANS TESTED THE MATTRESS AND NO LEAKS WERE FOUND. BASED ON THE LIMITED INFORMATION PROVIDED, A DEVICE MALFUNCTION CANNOT BE CONFIRMED. THE COMPLAINT COULD NOT BE VERIFIED, AND THE UNDERLYING CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

D

Patient 1

THE END-USERS WIFE CALLED AND ADVISED THAT HER HUSBAND HAS BED SORES ON HIS BACKSIDE DUE TO THE MA65 MATTRESS NOT WORKING PROPERLY. THE DEALER ADVISED THAT THE END-USER IS RECEIVING WOUND CARE OF CLEANING, DEBRIDEMENT, IRRIGATION, AND LIDOCAINE FOR PAIN.