MAUDE Adverse Event Report: TITANIUM GALLBLADDER CLIP; CLIP, IMPLANTABLE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Rash (2033); Dizziness (2194); Arthralgia (2355); Cognitive Changes (2551)

Event Date 04/23/2021

Event Type  Injury  

Event Description

Had severe joint pain, rashes, food allergies, brain fog; right hand side horrible pain, digestive issues, dizziness, full body inflammation from metal titanium clips used after gallbladder removal.I have rejected other implants and asked them not to use them but they did anyway.This resulted in two years of old symptoms returning and my quality of life being diminished.My surgeon in (b)(6) would not remove them so i had to fly to (b)(6)and had them removed two days ago.I can already feel marked improvement in brain clarity.I asked for sutures and he said no this is how we do it.It was emergency gallbladder removal so i didn't have a choice.We should have a choice.Titanium clips have nickel alloy.I stay away from conventional medicines because i overreact to side effects now.These implants devices change the way we react and make us hyper sensitive to everything.Fda safety report id# (b)(4).

• Brand Name: TITANIUM GALLBLADDER CLIP
• Type of Device: CLIP, IMPLANTABLE
• MDR Report Key: 11738113
• MDR Text Key: 248075706
• Report Number: MW5101051
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 64