MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE¿ MH 555CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341352
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Cancer (3262); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: na 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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a caucasian female patient who underwent an unspecified breast augmentation with a mentor memoryshape, 555cc silicone breast implant, experienced bilateral neoplasm malignant postoperative.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.No further information was provided regarding this case.Should more information become available, this case will be re-assessed, and notes will be updated.This report relates to the left prosthesis.
Additional Manufacturer Narrative
According to the information provided in crf (imedidata), at the time the reporting determination was made, this complaint is deemed not reportable as not related to the breast implants and the performed implant surgery.Therefore, removed, pc - neoplasm malignant, serious injury pec - adverse event and added, pc - new pc code (to capture tumor malignant not in the breast tissue), insufficient information, pec - no product quality issue manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE¿ MH 555CC
• 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: 15764661
• Report Number: 1645337-2022-13599
• Device Sequence Number: 18200031
• Product Code: FTR
• UDI-Device Identifier: 00081317005230
• UDI-Public: 00081317005230
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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: 04/26/2023
• Device Model Number: 3341352
• Device Catalogue Number: 3341352
• Device Lot Number: 7571483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 11/02/2022; 12/06/2022; 04/04/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 11/21/2022; 12/27/2022; 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2018
• 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: Other
• Patient Sex: Female