FDA.reportPublic FDA data

MAUDE MDR 8122274

MDR report key
8122274
Report number
1419507-2018-00005
Event key
0
Event type
3
Date received
2018-12-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. 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 WHEELCHAIR CUSHIONWHEELCHAIR CUSHIONROHO, INC.KICR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-0101. H; 2. O

Event Narratives#

N

Patient 1

ROHO, INC. WAS NOTIFIED OF THE ALLEGED INJURY BY THE CUSTOMER'S LEGAL COUNSEL AND IS UNABLE TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION. THE SPECIFIC MODEL OF THE DEVICE, SERIAL NUMBER, AND MANUFACTURING DATE ARE UNKNOWN. THEREFORE, WE ARE UNABLE TO REVIEW MANUFACTURING RECORDS FOR THE PRODUCT. THE DEVICE HAS NOT BEEN RETURNED SO WE CANNOT PERFORM AN INVESTIGATION ON THE DEVICE ITSELF. WE'VE REVIEWED OUR EXISTING COMPLAINTS AND FOUND NO OTHER SIMILAR COMPLAINTS ON FILE. IF WE RECEIVE ADDITIONAL INFORMATION, WE WILL SEND A FOLLOW-UP REPORT. THE CUSTOMER CLAIMED THERE WAS AN INJURY. HOWEVER, WE ARE NOT ABLE TO ACCESS MEDICAL RECORDS TO CONFIRM.

D

Patient 1

CUSTOMER CLAIMS THAT THE INFLATION VALVE ON A ROHO PRODUCT PUNCTURED HIM LEADING TO AN INJURY AND BONE INFECTION THAT REQUIRED TWO SURGERIES.