MAUDE Adverse Event Report: TELEFLEX MEDICAL TELEFLEX WECK HORIZON SURGICAL CLIPS (TORTURE DEVICES); CLIP, IMPLANTABLE

Model Number IT'S ON THEIR WEBSITE, 4MM CLIPS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Depression (2361); Foreign Body In Patient (2687)

Event Date 05/22/2020

Event Type  Injury  

Event Description

Major depression from pain; regrettably had a thyroid lobectomy on (b)(6) 2020.The general surgeon put many surgical clips or pieces of metal in my thyroid area and neck without my knowledge or consent.These clips have caused me so much constant pain, irritation, poking each time i swallow, talk, turn my head.If i had known foreign bodies/pieces of metal would be put in my small, delicate, nerve-filled neck, i never would have had surgery.There were other options.This surgeon disabled me from making an informed decision about my care.It's shocking to know that this secretive clip placing is done all over the world.Clips are put in necks, breasts and other body parts without the patients knowledge and consent.It is so wrong.There are a lot of people suffering from clip pain, allergies to the alloys, etc., from these so called 'inert' clips.They are not inert and why are they being put into people's bodies without their knowledge? then the hard part is trying to find a surgeon willing to remove them.I flew from (b)(6) last month to try and get these horrible pieces of metal removed from my thyroid area.The surgeon found and removed 3 but i still have at least 2 that i know of in me.I will have to endure a 3rd surgery to try and remove one that is in a risky spot but it's the foreign object that is bothering me.I asked the surgeon who secretly put this metal in me to remove them.He said, "what if i can't find them?" he can put them in me but can't remove them? that's because these foreign objects retract once placed on an artery.Who knows where they will land once put onto an artery.Retraction.And they migrate.They irritate the surrounding structures, poke and prod.It's jaw dropping that this surgeon did this to me.His operative report states "clips were placed." he doesn't even know how many he put in me.Disgusting.Fda safety report id # (b)(4).

Event Description

Additional information received from reporter on 11/12/2021 for report mw5102663.Just look at my past complaints that no one has done anything about.When will the fda, etc.Require surgeons to tell patients about the use of surgical clips in all types of surgeries? when? patients have the right to know before a surgery that pieces of sharp metal may be put in them.And, so the patient can make an informed decision to run and go to another surgeon who doesn't use clips.It is so wrong that this secretive clip placing is happening all over and no surgeons or device manufacturers are held accountable while many patients are suffering from these torture devices.Clips are not inert.Many people are allergic to the metal.They migrate and can be camouflaged on xrays hiding white on white on the bones.Many people feel pain, poking, sharpness, irritation, soreness which leads to depression and worse.Stop this unethical practice, please.One is lodged between my trachea and esophagus because of retraction of clips when put on superior thyroid artery.Or perhaps the gun misfired and this one clip fell in me and landed there.How nice, huh? these clips have ruined my life, thus ruining my teenage boys' lives/future.Biggest betrayal of my life having dr.John shaver in mission viejo, ca put these in me without my knowledge/consent.How dare he/others be allowed to put these in patients without telling them first so we (they) can make an informed decision.Fda safety report id # (b)(4).

• Brand Name: TELEFLEX WECK HORIZON SURGICAL CLIPS (TORTURE DEVICES)
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 12203234
• MDR Text Key: 262951976
• Report Number: MW5102663
• Device Sequence Number: 1
• 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,Followup
• Report Date: 07/18/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IT'S ON THEIR WEBSITE, 4MM CLIPS
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability; Required Intervention; Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White