inforMED
MalfunctionFHA

UROCLAMP

Received Sep 12, 2017 · Event occurred Aug 23, 2017

Report MW5072106 · MDR key 6857692

Device

Generic name

Uroclamp

Manufacturer

Unk

Lot number

NA

Product problems

  • Product Quality Problem

Patient

Not reported

  • Hematuria
  • Hematuria

Narrative

Description of Event or Problem

MY FATHER HAS BEEN USING DIFFERENT INCONTINENCE CLAMPS SINCE HIS CANCER PROSTATE SURGERY BACK IN 2014, HE HAS USED SEVERAL BRANDS AND TYPES OF CLAMPS (CUNNINGHAM, DRIBBLESTOP, WIESNER AND OTHERS), LAST MONTH I ORDERED HIM A NEW CLAMP AVAILABLE ON (B)(6) CALLED UROCLAMP, AFTER A FEW DAYS HE BEGAN BLEEDING WHEN URINATING. I TRIED TO CONTACT THE COMPANY TO EVALUATE THIS EVAL BUT FOUND NO CONTACT POINT, I EVEN RESEARCHED THE FDA REGISTERED MFRS FOUND THAT THIS DEVICE IS BEING SOLD ILLEGALLY IN THE US AS THEY HAVE NO FDA REGISTRATION OR LISTING. PLEASE EVALUATE THIS OFFERING AS THE PRODUCT HAS SEVERAL QUALITY PROBLEMS WHEN COMPARED TO OTHER INCONTINENCE CLAMPS THIS CAN LEAD TO PROBLEMS JUST LIKE MY FATHER'S OR WORSE. THERE IS NO REGISTERED MFR, DISTRIBUTOR OR IMPORTER FOR THIS DEVICE AND THIS IS ILLEGAL. BEST REGARDS. (B)(6).