MAUDE Adverse Event Report: UROCLAMP

Device Problem Product Quality Problem (1506)

Patient Problem Hematuria (2558)

Event Date 08/23/2017

Event Type  malfunction  

Event Description

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).

• Brand Name: UROCLAMP
• Type of Device: UROCLAMP
• MDR Report Key: 6857692
• MDR Text Key: 85960382
• Report Number: MW5072106
• Device Sequence Number: 1
• Product Code: FHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 83