MAUDE Adverse Event Report: UNKNOWN CLIP; CLIP, IMPLANTABLE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Itching Sensation (1943); Burning Sensation (2146); Urticaria (2278); Arthralgia (2355)

Event Date 11/19/2018

Event Type  Injury  

Event Description

Had my gallbladder removed.Did not know they put metal clips in.Ten days after the surgery, experienced huge burning welts all over my body including the bottom of my feet.Constant itch, chronic fatigue, inflammation of my joints, pain around where the gallbladder was u to my right shoulder.Immediately went to the er and was told i have stress included allergy.Called the surgeon and explained to the nurse my symptoms and letting her know that i know it's from these metal clips, as i knew i had an allergy to metals already.Was told that's an impossibility and go see an allergist.Seen my primary doctor first and explained my symptoms to the pa.She sympathized with me and said it sounded like a reaction to the clips.Besides smoking, i was a healthy (b)(6) year old man.She also suggested i see a allergy doctor, went to an allergy doctor, did patch test in which they had none for titanium, and came back allergic to nickel and manganese, he also said it was an impossibility of me reacting tithe clips.Got put on xyal and allegra twice a day.That kept the burning feeling at bay but continued welts not hives, huge welts all over my body as well as worsening fatigue and body pain.Since the allergy pills were not helping much he wanted to start me on xoclair injections.Quick to prescribe meds that cost a fortune and keep the sick sick if not sicker instead of finding the cause.Stopped seeing that allergy doctor.Called this surgeon again and explained to the nurse that i know this is an allergic reaction to the clips.She suggested i see an allergy doctor that does titanium testing.They found one for me and i made that appointment.This allergy doctor was my savior.He did all the patch test again, and again allergy to nickel and manganese.Showed him the pictures of my welts and he had never seen such an reaction.He was also convinced this was from the clips because of their impurities and contacted my surgeon.Then and only then the surgeon made an appt for me to see him.He was able to obtain the instrument with the clips that they used for my surgery.He placed 4 clips on my back with tape, almost immediately i reacted, fifteen minutes later it was confirmed to the surgeon that i in fact was having a reaction to the clips.My removal surgery was (b)(6) 2019.Almost immediately i felt better and no longer suffer with those horrible symptoms.I think it should be mandatory to tell patients clips go in with gallbladder removal.Also, these "titanium" clips should just be titanium no impurities; 1.8 million recorded allergy to titanium to me is not rare.This should be fixed, once upon a time clips weren't used when the gallbladder was removed.To me this sounds like a good way to have more sick patients.More damage is done mentally than physically because of doctors not believing their patients.Fda safety report id # (b)(4).

• Brand Name: CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9250043
• MDR Text Key: 164664975
• Report Number: MW5090750
• 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
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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): Hospitalization
• Patient Age: 52 YR
• Patient Weight: 91