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

Catalog Number 001200

Device Problems Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)

Patient Problems Failure of Implant (1924); Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 05/22/2020

Event Type  Injury  

Event Description

When will the fda require consent for clip use? how dare surgeons be allowed to put clips (foreign bodies) in patients without their knowledge or consent.Please see attached xrays.These four people have had clip removal surgery and we still have clips in us because they are hard to find in the thyroid area.They are risky to remove especially the ones stuck up high near the top of trachea and esophagus, sitting on the esophagus.They are painful.The clips on the top xray and the ones removed with all the tissue are made by teleflex medical/weck horizon clips.What if this was done to you or your family member?; (toture devices).Fda safety report id # (b)(4).

• Brand Name: TELEFLEX WECK HORIZON SURGICAL CLIPS
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 12851957
• MDR Text Key: 281206243
• Report Number: MW5105484
• 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: 11/18/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 001200
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Disability; Hospitalization; Life Threatening
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White