MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3544250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient underwent a breast augmentation revision surgery with implantation of a 250cc mentor memorygel breast implant prosthesis.Post-operatively, the patient was dissatisfied with her silicone implants.As a result, the patient underwent bilateral removal without replacements on (b)(6) 2023.During the surgery, a ruptured right breast implant was discovered.There were no reported procedural delays or patient consequences due to the discovery.The date of implantation was provided to mentor as a best estimate.Several follow-ups have been conducted, and no additional information has been received.If more information becomes available, mentor will submit a supplemental report accordingly.This report is for the left breast prosthesis.Refer to manufacturing report number 1645337-2023-09757 for the contralateral event.
Additional Manufacturer Narrative
The product was returned to mentor for evaluation.Mentor conducted a visual inspection of the device.During the visual evaluation, no apparent damage or visual anomalies were observed on the breast implant device.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.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.  if certain information is unknown, not available or does not apply, the section/field of the form is left blank.Reason for device explant and/or reoperation: patient dissatisfaction with procedure outcome h6 health effect - clinical code e2402: patient dissatisfaction with procedure outcome manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: 17839865
• Report Number: 1645337-2023-11428
• Device Sequence Number: 7760627
• Product Code: FTR
• UDI-Device Identifier: 00081317001027
• UDI-Public: 00081317001027
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/30/2020
• Device Catalogue Number: 3544250
• Device Lot Number: 7278925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White