FDA.reportPublic FDA data

MAUDE MDR 6798214

MDR report key
6798214
Report number
1419507-2017-00002
Event key
0
Event type
3
Date of event
2017-07-17
Date received
2017-08-16
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
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? HIGH PROFILE? SINGLE COMPARTMENT CUSHIONSENSOR READY WHEECHAIR CUSHIONROHO, INC.KIC1R1011H-CA-SRR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-1601. R

Event Narratives#

N

Patient 1

THE CUSTOMER AND HIS WIFE STATED THEY DID NOT BELIEVE THE CUSHION WAS LEAKING OR OTHERWISE MALFUNCTIONING, BUT INDICATED THAT HE SLIPPED ON THE CUSHION WHILE USING IT IN THE CAR. THEY DID NOT STATE HE FELL OFF THE CUSHION. THE CUSTOMER'S WIFE INDICATED THAT SHE REPOSITIONED HER HUSBAND SO HE WAS BACK IN THE ORIGINAL LOCATION ON THE CUSHION WHEN HE HAD SLIPPED. THEY BOTH STATED THEY FELT THE CUSHION WAS INFLATED PROPERLY (DID NOT HAVE TOO MUCH OR TOO LITTLE AIR). HE DID, HOWEVER, STATE THAT THE CUSHION FELT UNCOMFORTABLE. THE CUSTOMER STATED HE USED THE CUSHION FOR ABOUT 4-6 WEEKS BEFORE THEY NOTICED THE INJURY. THEY STATED THEY RECEIVED A REPLACEMENT CUSHION AFTER THE VA DID PRESSURE MAPPING. THE REPLACEMENT CUSHION HAD A GEL INSERT AND A RIGID FOAM BASE. ROHO, INC. DOES NOT MANUFACTURE CUSHIONS WILL GEL INSERTS. THE CUSTOMER DID NOT KNOW THE BRAND NAME OR MODEL OF THE REPLACEMENT CUSHION. HIS WIFE INDICATED THAT THE REPLACEMENT CUSHION WAS PAINFUL DUE TO THE RIGID FOAM AND WAS NOT BEING USED. SHE MADE CUSHIONS HERSELF AND THEY BELIEVE THOSE CUSHIONS ARE WORKING. WHILE THE CUSTOMER MADE THE CLAIM OF A SERIOUS INJURY, ROHO HAS NOT SEEN MEDICAL RECORDS TO CONFIRM THIS. ROHO SENT THE CUSTOMER A (B)(6) LABEL FOR THE CUSHION AND SMART CHECK TO BE RETURNED FOR EVALUATION, BUT THEY HAVE NOT ARRIVED YET. IF THEY ARE RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS. BECAUSE THE CUSHION HAS NOT YET BEEN RETURNED, ROHO REVIEW THE DEVICE HISTORY RECORD FOR SERIAL (B)(4) AND FOUND THAT IT WAS MADE ACCORDING TO THE SPECIFICATION IN THE DEVICE MASTER RECORD.

D

Patient 1

THE CUSTOMER STATED THAT HE AND HIS WIFE WERE DRIVING AND HE WAS USING HIS CUSHION IN THE CAR. HE KEPT SLIDING ON THE CUSHION AND HIS WIFE HAD TO SLIDE HIM BACK ON THE CUSHION. HIS WIFE STATED THAT THE CUSHION CELLS CAUSE IRRITATION WHEN SHE PLACE HIM BACK ON THE CUSHION. THE CUSTOMER CONTINUED TO USE THE CUSHION UNTIL THEY SAW A HOLE BETWEEN HIS BUTTOCKS AND THIGH, AT WHICH TIME HE WAS SEEN BY THE VA MEDICAL CENTER. HE SAID THE HOLE/WOUND ALMOST WENT DOWN TO THE BONE.