MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK HORIZON STERILE TITANIUM SURGICAL BREAST CLIPS; CLIP, IMPLANTABLE

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Cancer (3262); Unspecified Blood or Lymphatic problem (4434)

Event Date 01/15/2023

Event Type  Injury  

Event Description

Teleflex week horizon sterile titanium surgical breast clips were put into control bleeding during surgery they are permanent.I have developed lymphadenopathy titanium is known to affect the lymphatic system.They are known to affect b and t cells.I have bone marrow cancer it was nonhodgekin lymphoma and acute lymphocytic leukemia i've had several transfusions of blood and platelets and two kinds of chemotherapy.These should never have been used.My breast surgeon is going to be removing them.Due to severe pain and limited range of my right arm, it was the right breast lumpectomy and sentimental node under my right arm that was removed to resolve this, we have tried 2 rounds of physical therapy; 1 of occupational therapy we tried medication which after one tablet i reacted and doctor discontinued it.I have had two injections in my neck which had no effect on the pain.Test have not been down yet they will be done before surgery.I have been checked for shingles blood test to check for infection negative results.

• Brand Name: WECK HORIZON STERILE TITANIUM SURGICAL BREAST CLIPS
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 18676333
• MDR Text Key: 335117765
• Report Number: MW5151232
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE
• Patient Outcome(s): Disability
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White