FDA.reportPublic FDA data

MAUDE MDR 25191794

MDR report key
25191794
Report number
3014159402-2026-00002
Event key
0
Event type
3
Date of event
2024-12-17
Date received
2026-05-15
Adverse event
1
Product problem
0
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
MR. PRESTON LINES
Address
1443 W 800 N STE 303 OREM UT 84057 US
Phone
877-877-8772
Report source
M

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
138684RESTOREXPENILE TRACTION DEVICEPATHRIGHT MEDICAL, INC.LKYRESTOREX #117L-67NN
583835RESTOREXPENILE TRACTION DEVICEPATHRIGHT MEDICAL, INC.LKYRESTOREX #117L-67NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12026-05-150O

Event Narratives#

N

Patient 0

MANUFACTURER REVIEW DETERMINED NO DEVICE MALFUNCTION OR DEFECT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CUSTOMER REPORTED USE AT MAXIMUM TENSION SETTINGS OVER AN EXTENDED PERIOD. SUPPORTING MEDICAL RECORDS AND IMAGES WERE REQUESTED BUT NOT PROVIDED. BASED ON AVAILABLE INFORMATION AND MEDICAL REVIEW, THE REPORTED INJURY COULD NOT BE VERIFIED AND NO CAUSAL RELATIONSHIP TO THE DEVICE COULD BE ESTABLISHED BASED ON AVAILABLE INFORMATION.

D

Patient 0

CUSTOMER REPORTED THAT USE OF THE RESTOREX DEVICE RESULTED IN A TEAR IN THE CORPUS SPONGIOSUM, WORSENING ERECTILE FUNCTION, URINARY INCONTINENCE, AND ONGOING PAIN AND INFLAMMATION. THE CUSTOMER STATED THE DEVICE WAS USED ACCORDING TO INSTRUCTIONS, INCLUDING USE AT MAXIMUM TENSION SETTINGS OVER AN EXTENDED PERIOD. PATHRIGHT REQUESTED SUPPORTING MEDICAL RECORDS AND IMAGES TO EVALUATE THE ALLEGATIONS; HOWEVER, NO DOCUMENTATION WAS PROVIDED. BASED ON AVAILABLE INFORMATION AND INTERNAL REVIEW, THE REPORTED INJURIES WERE NOT VERIFIED, AND NO CAUSAL RELATIONSHIP TO THE DEVICE COULD BE ESTABLISHED.