MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS; EXPANDER, SKIN, INFLATABLE

Model Number 3549212

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Device evaluation summary: a blind device received under claim (b)(4) with lot #: 9443912 product evaluation lab on 2/26/2021 with no complaint information attached and could not be associated with an existing complaint.The product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the med height te w/sut tabs 350cc breast implant was found to be intact.Reason for device explant and/or reoperation: insufficient information.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a female patient who underwent breast surgery with a 350cc mentor cpx 4 breast tissue expander with suture tabs experienced an unspecified complication post procedure.As a result, patient had an explantation on (b)(6) 2021.Dates of implant and explant have been estimated based on the manufacturing date of the device and the date of receipt at mentor, respectively.

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 11572939
• MDR Text Key: 242394379
• Report Number: 1645337-2021-03246
• Device Sequence Number: 1
• Product Code: LCJ
• UDI-Device Identifier: 00081317006725
• UDI-Public: 00081317006725
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2024
• Device Model Number: 3549212
• Device Catalogue Number: 3549212
• Device Lot Number: 9443912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Date Manufacturer Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2020
• 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 Outcome(s): Required Intervention