MAUDE MDR 6818745

MDR report key
6818745
Report number
1419507-2017-00003
Event key
0
Event type
3
Date of event
2017-01-01
Date received
2017-08-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
107
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. ROBIN GERGEN
Address
100 N. FLORIDA AVE. BELLEVILLE IL 62221 US
Phone
800-800-8008
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ROHO? QUADTRO SELECT? CUSHIONWHEELCHAIR CUSHIONROHO, INC.KICR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-2401. H

Event Narratives#

N

Patient 1

THE CALLER STATED THAT THE NURSING STAFF AT THE NURSING HOME DID NOT MONITOR THE PATIENT'S SKIN AS THEY SHOULD HAVE. SHE STATED THAT THE NURSES SHOULD HAVE NOTICED ANY INJURY WHEN THEY WERE BATHING THE PATIENT OR CHANGING HER CLOTHES WELL BEFORE IT IS REQUIRED HOSPITALIZATION. SHE WAS CONCERNED THAT THE FACILITY WAS BLAMING THE INJURY ON THE CUSHION INSTEAD OF FOLLOWING UP WITH THE NURSING STAFF TO ENSURE THEY WERE TRAINED ON PROPER USAGE OF THE CUSHION. THE CALLER DID NOT HAVE ACCESS TO THE CUSHION IN ORDER TO SEND IT TO ROHO FOR EVALUATION. SHE DID NOT KNOW THE MANUFACTURING DATE, CUSHION MODEL, OR SERIAL NUMBER, SO ROHO HAS BEEN UNABLE TO PERFORM A REVIEW OF MANUFACTURING RECORDS.

D

Patient 1

THE CALLER STATED A PATIENT WAS IN THE HOSPITAL WITH A NEARLY STAGE IV PRESSURE ULCER AND NEEDED A TEMPORARY COLOSTOMY BECAUSE THE WOUND WAS CLOSE TO THE ANAL OUTLET. SHE STATED THE NURSING STAFF CLAIMED THE INJURY WAS CAUSED AFTER THE PATIENT SAT ON A ROHO QUADTRO SELECT CUSHION WITH A FLAT QUADRANT FOR WEEKS.