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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL CLIPS; CLIP, IMPLANTABLE

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SURGICAL CLIPS; CLIP, IMPLANTABLE Back to Search Results
Model Number SEE PICTUTRE
Device Problems Entrapment of Device (1212); Device Appears to Trigger Rejection (1524); Improper or Incorrect Procedure or Method (2017); Migration (4003)
Patient Problems Emotional Changes (1831); Fatigue (1849); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Fluid Discharge (2686); Device Embedded In Tissue or Plaque (3165); Skin Inflammation/ Irritation (4545)
Event Date 07/16/2004
Event Type  Injury  
Event Description
Infected and toxic; i have never felt right.I feel it now more than ever.Please help me this is not normal.I just need 1 person to fight for me.Don't limit me because the law says so.I would not be emailing, crying, begging and reaching out if they just told me 17 years ago and removed it properly 11 years ago.I am the one who suffered the consequences and the neglect of these doctors, hospitals, lawyers everyone just assumed the clips were made to be in a body with no effect they were wrong.Statue of limitation is all i get when is my statue of limitation over on my medical needs and continuous suffering.There is a long term effect and should not be limited because of the so called law.I want to live my life without these clips inside of me that i never knew i was getting in the first place why do you allow this to happen? how do you think this is ok to do to people.They never told me when it was done.They never told me after no doctors, no hospital, x-rays, ct scan, ultrasounds, sonograms never mentioning clips.They allowed me to suffer in pain for 6 years before finding out.Lost work, time, finance.I was unable to give natural birth because they were in the way.Forced to have c-section.Just removed no further action taken.Infection, scar tissue? stitches burst open and pink smelly pus.Never feeling right.Always with high white blood cell count.Infection.Doctors don't care to do extra (so quick to give pills) irritation on my skin.No other pregnancy.My quality of life taken from me.No trust in doctors.No trust in lawyers.Was my case ever filed? who made the decision to dismiss? serendipity he said titanium clips have no affect they said says who? why aren't clips disclosed or even counted? affected my relationship with my parents to my father apologizing to me after finding out about the clips.Everyone shutting me down 17 years later still suffering the consequences in the hands of the doctors.Ptsd, chronic fatigue syndrome.Statute of limitations, defamation of character and cease and desist.Everyone just keeps failing me please help me i am not here to cause trouble i am trying to bring awareness to surgical clips.Surgery was (b)(6) 2004.I did not feel well after surgery as i was in and out of pain lower right side.I went back to the doctor a few times and he assured me everything was ok.I went back to my regular doctor and he said the same thing i went to the hospital a few times but again no one saw anything and just treated me with bad pms.(b)(6) 2004 i was rushed to the hospital where i stayed for approximately 10 days.They ran so many tests, scans and xrays.I remember 1 x-ray seeing something and when i asked the so called doctor, said it was part of the machine.Sent me home not finding anything wrong.I spent 6 years in so much pain every month visiting the hospital over 100x and no one helped, found or even really tried to find out what was wrong with me.Fast forward to 6 years later i finally got pregnant.Though my pregnancy was amazing, my labor was not.Trying to give birth naturally, my daughter would not come out.She would keep going back in after almost 3 hours of trying to push her out.They called an emergency c-section due to the baby losing too much oxygen.Laying at the hospital feeling and hearing them cut me the doctor asks me "(b)(6) what was your last surgery" i said oh my god did you find something? and sure enough he did.Doctor pulls out 2 metal open clips before taking my baby out.I did not experience that first touch as they needed to attend to her and they had to finish me up.Waking up hours later in disbelief of what the profanity just happened.Long story short.After years wasted, trying to find out what really happened, hiring an attorney.Doctor after doctor not wanting to admit to anything or go against another fellow doctor, specialist and waste of an attorney.Being told by these so-called doctors: "your baby is ok, you¿re ok just go on with your life." it's serendipity" "these clips were made to be in your body causing no damages." "these clips are made to fall if no longer needed" the main concern of the medical profession with clips is a possible allergy to nickel, they feel they are covered because the patient intake form requires patients to state if they have any allergies.If the patient doesn't mention an allergy to nickel, they feel it is safe to proceed.There is some awareness of the myriad of problems caused by clip migration, but since it is not very common it's simply not on their radar.I think that raising awareness in cholecystectomy patients is a sound approach, though since many have emergency surgery, they may never find out that titanium alloy clips have been used.All the hospitals for assuming i was just pms giving me iv and pain meds let me sleep it out dr.(b)(6) for not adding these findings in his report and not looking further into it to ensure there were no damages caused by foreign objects inside me for 6 years.I can get over 60 people who witness me just drop to the floor when the pain would start and i would be unable to move for hours.Most comfort was in a tub with hot water to alleviate the pain.The attorney after i reached out to him again confirming in 2012 that the 3 clips are still in place and the 2 found were obviously extra, as the specialists¿ findings were wrong.Never fought for me.Ws center never disclosed that clips were used and inserted.They failed to tell me, the doctors refused to tell me.Those clips are not safe and needs to be disclosed.I suffered for years and continue to suffer because of the mistake of the insertion and migration of these clips.Actual clips that were removed during c-section attached.Shame on you i know i am not the only one and i will bring awareness.The fact that these doctor can still drop surgical clips because there is no disclosure and live a nice happy life while their patient suffered years of pain, mentally and physically, all the money i spent in doctors and hospitals, loss of employment, loss of time, unable to function day to day.All my life i have been fighting, defending, see corruption first hand in all aspects and years of my life.Cover up, protecting their own.Payoffs.What doctor what's to go against another doctor.Fda safety report id # (b)(4).
 
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Brand Name
SURGICAL CLIPS
Type of Device
CLIP, IMPLANTABLE
MDR Report Key11463382
MDR Text Key239694904
Report NumberMW5099958
Device Sequence Number2
Product Code FZP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/08/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberSEE PICTUTRE
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Congenital Anomaly; Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age31 YR
Patient Weight86
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