MAUDE Adverse Event Report: TELEFLEX / TELEFLEX MEDICAL WECK HEM-0-LOC CLIP; CLIP, IMPLANTABLE

Device Problems Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Emotional Changes (1831); Hemorrhage/Bleeding (1888); Urinary Incontinence (4572)

Event Date 08/21/2020

Event Type  Injury  

Event Description

On (b)(6) 2011, entered (b)(6) for a proctectomy by robotic surgery due to cancer.At the time of the surgery, dr.(b)(6) put 4 of these non-dissolvable hem-o-loc clips in me.I did not know they used until the first one migrated into my bladder.The clips are used to control the lateral pedicles.I was continent soon after surgery until 2020.Fast forward to (b)(6) 2020, started passing blood, surgery with scope on (b)(6) 2020, doctor said it look like a mesh support was coming through my bladder, he never put a mesh support in me.Turns out it was a weck hem-o-lock clip that had come loose and entered into my splinter mussel.Clip was removed.Told i would leak some, not so, i self catheterized myself for over three months and then in (b)(6) 2021 i started leaking constantly.Fast forward to (b)(6) 2021, started passing blood again back to surgery on (b)(6) 2021 two more clips were removed from the neck of my bladder, still incontinent, leaked, and self catheterized my self until (b)(6) 2021 back in for surgery again to remove the fourth clip from the lower left side of my bladder.Still incontinent, leaking constantly.As of today (b)(6) 2021 still incontinent.To my knowledge the maker of this clip has not been notified, nor has the fda been informed of a surgical clip failure.Teleflex inc.Is the maker of the clip.I called the teleflex company and ask them if anybody had reported this to them, they said no.There have been major problems with this product from 2006 forward.(b)(6), this article explains the complications of this clip.This is no big secret and i do not know why they continue to use them.It has completely destroyed my life as i knew it before (b)(6) 2020 when the first of the clips were removed.During this time frame i had several ct scans with and without contrast.My doctor through out this was dr (b)(6) with associated urology, at (b)(6).Dr.(b)(6) told me that the ct scans would not pick up the clips but i later found where they would online.These clips have ruined the quality of my life.I cannot travel or attend anything over an hour and a half.I told dr (b)(6) my life sucks, he said i feel your pain, i told him he was not the one who was having to live it.I ask him if he reported the clip failure to fda and the clip maker, and he said, no.I want answers on why my life has been completely turned upside down, bed wetting, wet pads between my legs all the time, wetting myself out in public when my pad will not hold, this is not my fault, i did not make the clip, i did not do the surgery to put it in.Either this product is faulty or is not installed properly during surgery.Please help me.I have read about 4 other men who had clip migration into the splinter mussel and they have never regained continence.In the last year this mistake by either the doctor or the clip maker has cost me out of pocket for hospital bills, catheters and pads and scans of around (b)(6).Fda safety report id# (b)(4).

• Brand Name: WECK HEM-0-LOC CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX / TELEFLEX MEDICAL
• MDR Report Key: 12787690
• MDR Text Key: 280766876
• Report Number: MW5105242
• Device Sequence Number: 4
• Product Code: FZP
• 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
• Type of Report: Initial
• Report Date: 11/07/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: ASPIRIN ; BASAGLAR; GLIPIZIDE ; LISINOPRIL ; MOTRIN ; NORVASC ; PANTOPRAZOLE; ROSUVASTATIN ; TIZANIDINE ; VENLAFAXINE ; WATER PILL
• Patient Outcome(s): Required Intervention; Hospitalization; Disability
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White