FDA.reportPublic FDA data

MAUDE MDR 6796448

MDR report key
6796448
Report number
1419507-2017-00001
Event key
0
Event type
3
Date of event
2017-07-13
Date received
2017-08-15
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? QUADTRO SELECT? HIGH PROFILE? CUSHIONWHEELCHAIR CUSHIONROHO, INC.KICQS910CY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-1501. H; 2. R

Event Narratives#

N

Patient 1

ON THE INITIAL CALL, THE PATIENT'S MOTHER STATED THAT SHE FELT THE CUSHION WAS NOT HOLDING AIR, BUT THAT THEY HAD BEEN UNABLE TO FIND A LEAK. HER SON DID NOT BELIEVE THERE WAS A PROBLEM WITH THE CUSHION. THEY CONTINUED TO USE THE CUSHION FOR A MONTH BEFORE THE WOUNDS WERE NOTICED. ROHO WAS UNABLE TO REPRODUCE THE DESCRIBED PRODUCT FAILURE DURING THE EVALUATION OF THE DEVICE. THE CUSTOMER CLAIMED HOSPITALIZATION AND SURGERY, HOWEVER, ROHO HAS NOT SEEN ANY MEDICAL RECORDS TO CONFIRM THIS.

D

Patient 1

THE PATIENT'S MOTHER CALLED TO STATE THAT HER SON WAS IN THE HOSPITAL WITH FOUR PRESSURE INJURIES. TWO ARE ON THE BOTTOM LOWER PART OF HIS CHEEK, ONE IS ON HIS COCCYX, AND ONE IS ON THE RIGHT SIDE OF HIS LOWER HIP. HE HAD SURGERY AND NEEDS 6 WEEKS OF ANTIBIOTICS. SHE STATED THE CUSHION HE WAS USING WAS NOT HOLDING AIR AND CAUSED THE INJURY.