MAUDE Adverse Event Report: MENTOR TEXAS MENTOR ROUND MODERATE PROFILE SINGLE USE SALINE BREAST IMPLANT SIZER; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Model Number 3503754BC

Device Problems Deflation Problem (1149); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2023

Event Type  malfunction  

Manufacturer Narrative

Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: pre-implant rupture.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that 375cc mentor memorygel breast implants being used for a breast augmentation procedure ruptured prior to implantation, and bubble was reported.There were no patient consequences or additional information reported.

Manufacturer Narrative

Per additional information received on september 7, 2023, the following information has been updated on this form: 1.Updated from lot number 9884487 to lot number 9873576 under field d4; information under section d has been updated accordingly 3.Per the lot number updated, product experience code was automatically removed.4.Added product experience code: deflation (pre-implant) 5.Reportability decision has been updated from malfunction to not reportable manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR ROUND MODERATE PROFILE SINGLE USE SALINE BREAST IMPLANT SIZER
• Type of Device: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 17259241
• MDR Text Key: 318438729
• Report Number: 1645337-2023-07802
• Device Sequence Number: 1
• Product Code: MRD
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3503754BC
• Device Catalogue Number: 351-225SZ
• Device Lot Number: 9873576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2023
• 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