FDA.reportPublic FDA data

MAUDE MDR 9752998

MDR report key
9752998
Report number
0001831750-2020-00304
Event key
0
Event type
3
Date of event
2020-01-21
Date received
2020-02-26
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. KELSEY BARLA
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, PATIENT ROTATION, POWEREDSTRYKER MEDICAL-KALAMAZOOIKZUNK_MEDN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-260

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A PATIENT ACQUIRED A DEEP TISSUE INJURY AND STAGE 4 PRESSURE INJURY WHILE LAYING ON A STRYKER MATTRESS. NO FURTHER INFORMATION ABOUT THE INJURIES OR TREATMENTS FOR THOSE INJURIES WAS REPORTED. ATTEMPTS HAVE BEEN MADE TO REACH THE CUSTOMER FOR MORE INFORMATION; HOWEVER, THE CUSTOMER HAS NOT RESPONDED TO THESE ATTEMPTS.