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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEMOCLIPS / SURGICAL CLIPS/ USED AT MEASE HOSPITAL; CLIP, IMPLANTABLE

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HEMOCLIPS / SURGICAL CLIPS/ USED AT MEASE HOSPITAL; CLIP, IMPLANTABLE Back to Search Results
Model Number N/A
Device Problem Entrapment of Device (1212)
Patient Problems Pain (1994); Sore Throat (2396); Device Embedded In Tissue or Plaque (3165); Cough (4457)
Event Date 03/08/2015
Event Type  Injury  
Event Description
Pain swallowing or drinking.In 2015, i underwent a thyroidectomy.After the surgery i told the doctor that i felt a poking feeling in my neck.The doctor said that it should go away after a few weeks.Months later, i still felt chronic pain every time i swallowed food or drank water and frequent coughing.I went to 6 ent doctors and two endocrinologist in the last 6 years.I was told to take several pain medications to treat an acid reflex that might have been causing the pain.Two different ent doctors placed me on acid reflex medication.I also has an endoscopy in 2019.Regardless, i followed each of their instructions to no avail.None of the medications helped alleviate my pain.In (b)(6) 2019, i was referred by a friend to see a chiropractor to help with my back pain.In the office, i told the chiropractor my story about the pain when i eat, and he told me that he needs to take x-rays before any treatment.From the x-rays he took, he found 27 clips in my throat and he asked me if i knew about this.I was surprised since no one previously told me about this.My chiropractor referred me back to my original surgeon to look for answers.In (b)(6) 2019, i set up an appointment with the surgeon dr.(b)(6), in (b)(6) and brought my x-rays.He was very defensive to all my questions and i asked why he never disclosed to me why he left so many clips.He told me that "he was not obligated to tell his patients his medical practice".I told him, yes you are obligated because it is my body and my life, and you left staples in my neck.He told me that he did not recommend to let any body do any type of surgery to remove the clips because the solution would be worse than what i'm dealing with now because the nerves in my neck could be damaged.And the only solution he told me to do is to for me to go a pain management clinic to deal with my pain and told me there is nothing else he can do.That day i left his office crying and i felt very miserable.Sometimes i did not want to continue living like this.While working or any place i always felt a constant pain.In (b)(6) 2020, i went to (b)(6) to see a specialist (ent) and the doctors that i set up the appointment did not bother to hear me what i need to say or even took the time to see my x-rays.The appointment was less than five minutes and told me that he is not the doctors that can remove the clips and he left the office (another careless doctor).In 2020, i could not do much because now the covid19 pushed me to work from home since my asthma.Always seeking for help, i decided to join an online group who had the same issues that i did because i would like to know if there is anybody with the same problem as me.On (b)(6) 2021.I enjoyed this group online and i posted my issues with the clips just to find out if any experienced the same problem.One of the members sent me a private message and told me she had the same issues and we started exchanging information and experience.She told me that there was a hospital in my area that could help me and gave me number to call and referred me to speak with a surgeon that specialized with thyroid and neck issue.The next day i called the office and left a message.Since no one called me after two days, i sent an email to the surgeon with the x-rays and told her my story.A day later, i received a phone call and the person who called me listened to all of my concerns and asked me when i wanted to set up an appointment for evaluation.I told her that it would be great if i can speak with the surgeon.She told me that she was the surgeon and said she would evaluate me.I started crying because i could not believe that i found somebody that cared to listen and showed interest in me.From the surgery, they removed ten surgical clips and 4 lymph nodes.After the surgery i can swallow without any pain.No surgeon should be using surgical clips especially if they are left in the sensitive part of the body like the neck.Fda safety report id # (b)(4).
 
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Brand Name
HEMOCLIPS / SURGICAL CLIPS/ USED AT MEASE HOSPITAL
Type of Device
CLIP, IMPLANTABLE
MDR Report Key11613277
MDR Text Key244181078
Report NumberMW5100550
Device Sequence Number1
Product Code FZP
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other;
Patient Age56 YR
Patient Weight63
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