FDA.reportPublic FDA data

MAUDE MDR 5147739

MDR report key
5147739
Report number
1419507-2015-00004
Event key
0
Event type
3
Date of event
2013-06-01
Date received
2015-10-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
MS. ROBIN GERGEN
Address
100 N. FLORIDA AVE. BELLEVILLE IL 62221 US
Phone
800-800-8003
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ROHO HIGH PROFILE CUSHIONWHEELCHAIR CUSHIONROHO, INC.KICN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-10-1401. O

Event Narratives#

N

Patient 1

WHILE REVIEWING THE MAUDE DATABASE ONLINE, REPORT NUMBER MW5043281 WAS FOUND. THERE IS NO CONTACT INFORMATION FOR THE PATIENT/REPORTER, SO ROHO IS UNABLE TO PERFORM A FULL INVESTIGATION OR EVALUATE THE DEVICE. BECAUSE A FULL INVESTIGATION WAS NOT POSSIBLE, ROHO WAS ALSO UNABLE TO CONFIRM ANY OF THE REPORTED INJURIES. THIS REPORT IS BASED SOLELY ON THE STATEMENTS MADE ABOUT ROHO HIGH PROFILE CUSHION IN THE MAUDE REPORT. BASED ON THE INFORMATION IN THE MAUDE REPORT, THE FOLLOWING EVALUATION WAS CONDUCTED REGARDING THE NAMED PRODUCT: 1. WHILE THERE WERE SEVERAL SEPARATE MENTIONS OF HIGH PROFILE CUSHIONS, ROHO IS UNABLE TO CONFIRM THE YEAR OF MANUFACTURE OR THEIR EXACT MODEL(S) AND THEREFORE CANNOT CONCLUDE THE TOTAL NUMBER OF HIGH PROFILE CUSHIONS USED BY THE REPORTER. 2. THE EXPECTED LIFE OF A ROHO CUSHION IS THREE YEARS BASED ON TESTING AND EVALUATION OF THE PRODUCT. BASED ON THE END USER'S CLAIM, THE 1997 AND 2006 CUSHIONS WERE BEING USED OUT OF THE EXPECTED LIFE OF SUCH CUSHIONS. ROHO'S PRODUCT SUPPORT POLICY ALLOWS FOR A TWO OR THREE YEAR WARRANTY PERIOD, DEPENDING ON THE EXACT MODEL OF THE CUSHION. 3. BASED ON THE INFORMATION INCLUDED IN THE REFERENCED MAUDE REPORT, THE COMPLAINANT IS REQUESTING THAT ROHO RE-CREATE THE DESIGN OF THE NAMED CUSHION PRODUCED IN 1997. HOWEVER, THIS DESIGN IS NO LONGER SUPPORTED BY THE COMPANY FOR REASONS INCLUDING OBSOLETE MATERIALS AND PRODUCT REDESIGNS. 4. FURTHER EVALUATION OF THE MAUDE REPORT CONCLUDED THAT THE COMPLAINANT IS ALLEGING A SIZE AND SHAPE CHANGE BETWEEN NAMED MODELS OF ROHO CUSHIONS. HOWEVER, ROHO HAS CONFIRMED THAT SINCE 1997-PRESENT, THE SHAPE AND SIZE OF THE CUSHIONS HAVE NOT CHANGED, AND CANNOT SUBSTANTIATE THE CLAIM NOTED. 5. THE REFERENCED MAUDE REPORT DID NOT INCLUDE ANY UNIQUE IDENTIFIERS, THEREFORE; ROHO WAS UNABLE TO REVIEW THE DEVICE HISTORY RECORD FOR THE SUSPECT PRODUCT(S). HOWEVER, ROHO DID CONDUCT AN INVESTIGATION TO DETERMINE IF SIMILAR COMPLAINTS HAVE BEEN RECEIVED REGARDING THE THICKNESS OF NAMED PRODUCTS CAUSING SERIOUS INJURY OF REPORTABLE MALFUNCTION. NO SUCH COMPLAINTS HAVE BEEN RECEIVED. DEVICE NOT RETURNED TO MANUFACTURER.

D

Patient 1

A VOLUNTARY REPORT FOUND DURING A REVIEW OF THE FDA MAUDE DATABASE WAS FOUND BY ROHO. IT INCLUDED THE FOLLOWING CLAIMS: 1. A "1997 HIGH PROFILE ROHO CUSHION" WAS NO LONGER WORKING IN 2013. 2. ADDITIONAL ROHO CUSHIONS WERE USED AFTER THIS, INCLUDING A "2006 HIGH PROFILE CUSHION", A "CURRENT HIGH PROFILE ROHO CUSHION", A "HIGH PROFILE ROHO QS" (ASSUMED TO BE A HIGH PROFILE QUADTRO SELECT CUSHION), AND A "LOW PROFILE". THE REPORT CLAIMS THAT ALL OF THESE CUSHIONS CAUSED EITHER INJURY TO THE END USER AND/OR RESTRICTED THE END USER'S MOBILITY. 3. THE END USER'S MEDICAL TEAM DESCRIBED THE INJURY AS LIFE THREATENING AND REQUESTED THAT ROHO REPLICATE THE 1997 CUSHION. 4. THE END USER HAS SINCE FOUND AND PURCHASED OTHER ROHO CUSHIONS THAT WERE MANUFACTURED IN THE 1990'S, WHICH DO NOT CAUSE INJURY, BUT ARE NOT THE CORRECT SIZE, SO THE END USER'S RANGE OF MOVEMENT IS RESTRICTED. THE REPORT ALSO CLAIMS THAT "OTHER ROHO CUSTOMERS HAVE BEEN COMPLAINING ABOUT THE THIN MATERIAL CURRENTLY USED IN THEIR CUSHIONS, WHICH CAUSED THEM SERIOUS HEALTH ISSUES. "