FDA.reportPublic FDA data

MAUDE MDR 8659553

MDR report key
8659553
Report number
1419507-2019-00002
Event key
0
Event type
3
Date of event
2019-03-13
Date received
2019-05-31
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
MRS. ROBIN GERGEN
Address
1501 S. 74TH STREET BELLEVILLE IL 62223 US
Phone
800-800-8008
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ROHO? MOSAIC? CUSHIONWHEELCHAIR CUSHIONROHO, INC.KICMOS1818CAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-3101. H; 2. O

Event Narratives#

N

Patient 1

DUE TO THE CUSTOMER'S INITIAL CONTACT HAVING LITIGIOUS UNDERTONES, COMPLAINT INFORMATION WAS TRANSFERRED TO LEGAL COUNSEL. THE DEVICE SERIAL NUMBER AND MANUFACTURING DATES ARE UNKNOWN- THEREFORE MANUFACTURING RECORDS FOR THE PRODUCT ARE UNABLE TO BE REVIEWED. THE DEVICE HAS NOT BEEN RETURNED, SO AN INVESTIGATION CANNOT BE PERFORMED ON THE DEVICE ITSELF. LEGAL COUNSEL CONTACTED THE END USER VIA TELEPHONE AND WAS INFORMED BY THE CUSTOMER THAT THEIR SALES CONTACT STATED THE MOSAIC CUSHION WOULD BE APPROPRIATE FOR A RECLINER. LEGAL COUNSEL QUESTIONED WHETHER THE REPRESENTATIVE WAS AWARE THAT THE RECLINER BEING USED WAS FOR A POWER LIFT RECLINER THAT WOULD ASSIST THE END USER WITH STANDING. THE END USER EXPRESSED UNCERTAINTY ABOUT THIS. THE END USER RECAPPED THE EVENT DETAILS TO LEGAL COUNSEL AND STATED THAT AT THE TIME OF THE ALLEGED INJURY THE RECLINER WAS BEING USED TO STAND UPRIGHT. THE MOSAIC CUSHION STAYED IN PLACE ON THE POWER LIFT RECLINERS SURFACE, BUT THE END USER SLID OFF THE CUSHION. THE END USER FEELS THAT THE CUSHION SHOULD HAVE KEPT THEIR BODY IN POSITION AGAINST THE ELEVATION. LEGAL COUNSEL EXPLAINED TO THE END USER THAT THE OPERATION MANUAL STATES THE CUSHION IS MEANT FOR A WHEELCHAIR AND EXPLICITLY WARNS AGAINST USING IT ON TOP OF OR WITH OTHER PRODUCTS. THIS INCIDENT IS CATEGORIZED AS A DEVICE USE ERROR SEEING AS HOW THE END USER UTILIZED THE DEVICE OUTSIDE OF ITS INTENDED USE. AN ADVERSE EVENT REPORT WILL BE SUBMITTED DUE TO THE SERIOUS INJURY ALLEGATION, BUT BASED ON THE INFORMATION INITIALLY OBTAINED, THE COMPLAINT DOES NOT MEET THE REQUIREMENTS SET FOR A REPORTABLE COMPLAINT IN THE MARKET THE DEVICE WAS SOLD. AT THIS TIME, NO ADDITIONAL CONTACT WILL BE MADE WITH THE END USER-EXCEPT THROUGH LEGAL COUNSEL, IF APPLICABLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

D

Patient 1

PER THE END USER, THEY WERE TRYING TO GET OUT OF THEIR POWER LIFT CHAIR RECLINER. THEY SLIPPED ABRUPTLY, FELL TO THE GROUND, AND THEIR LEFT LEG TWISTED UNDER THEM RESULTING IN BROKEN TIBIA AND FIBULA BONES. THE END USER WAS ADMITTED TO THE HOSPITAL AND A SURGICAL OPERATION WAS PERFORMED. THE INJURY OCCURRED THE FIRST MORNING THE END USER USED THEIR CUSHION. THE END USER REPORTS FOLLOWING THE GUIDE MANUAL STEP BY STEP AND BELIEVES THERE IS NO WARNING IN THE GUIDE ABOUT USING A POWER LIFT CHAIR RECLINER INFORMING THAT IT WOULD BE UNSAFE. THE END USER STATES THAT DUE TO THEIR AGE, THIS WILL PREVENT THEM FROM WALKING AGAIN, AND SEEKING LEGAL COUNSEL IS A POSSIBILITY.