MAUDE Adverse Event Report: TITANIUM METAL CLIPS; CLIP, IMPLANTABLE

Device Problem Misfire (2532)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Arthralgia (2355); Constipation (3274)

Event Type  Injury  

Event Description

I had my gallbladder removed in 2019 immediately following i had constant right side pain that radiated to my back.I also had severe pain in the middle just under my breast bone.I developed a rash for several weeks over the clip area.I also stopped having any natural bowel movements as if something was blocking my intestines.I went two years without a natural bowel movement.I develop joint pain, fatigue brain fog, food allergies worsened.I asked my doctor not to use clips since i had a history of rejecting foreign objects.He used them anyway.I went back several times regarding my constant pain and was dismissed as anxious instead of listened to.I knew it was the clips causing my issues.I found a surgeon in (b)(6) who removed clips from a (b)(6) group.My surgical report after gb removal stated i had three clips placed.The surgeon who removed them found three clips in the correct spot and then 6 more in a wad under my breastbone, my body formed a mass around them.The surgeon said they were misfires that were just left in there it looked like.After removal all my symptoms went away.My bowels started working again a month later.All my right side pain was gone.But having to travel to the one doctor in the country who believes these issues and doesn't reject you was a lot to go through.I live in (b)(6) so it was an ordeal.So i not only rejected them but had six extra misfires just sitting there causing extreme pain.I pray that you all take a better look at the safety of these metals.Saying they are inert is not the case.There are so many people suffering and in these groups just trying to be heard by their doctors.And instead are made to feel crazy.Titanium clips are not 100% pure i don't care what they say.Patients deserve a choice to have sutures instead of clips.I fear that something will happen to me in the future and more metal will be placed without my consent.I never want to go through what i went through again.I went to the er, primary, urgent care, gastro, a total of 19 times in two years related to this issue.Thank god for dr (b)(6).Bariatric surgeon in (b)(6) for giving me my life back.Not sure.Fda safety report id # (b)(4).

• Brand Name: TITANIUM METAL CLIPS
• Type of Device: CLIP, IMPLANTABLE
• MDR Report Key: 12634161
• MDR Text Key: 276838840
• Report Number: MW5104627
• Device Sequence Number: 1
• Product Code: FZP
• 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: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 45 YR
• Patient Weight: 64