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

Catalog Number SURGICAL UNKNOWN

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Mw5151232.

Event Description

Received via a medwatch report, the patient reported they developed lymphadenopathy in the right breast on 15 jan 2023 after breast surgery on (b)(6) 2022.The report further states, "titanium is known to affect the lymphatic system" and "these should never have been used." additional information received states that "i have the surgical report and there are no problems with placing them reported.I have the lymphoedema in my right breast, i have had radiation after the surgery".

• Brand Name: WECK HORIZON TITANIUM CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18954236
• MDR Text Key: 338279650
• Report Number: 3003898360-2024-00251
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 04026704410224
• UDI-Public: 04026704410224
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SURGICAL UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female