MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE¿ TH 610CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341354
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Post Operative Wound Infection (2446)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Additional 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: wound infection.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a caucasian female who underwent unspecified breast reconstruction surgery with a 275cc mentor memoryshape, 610cc breast implant experienced left sided infection post procedure.On (b)(6) 2021 incision drainage aspiration was performed on the left side and removal of the left implant.
Additional Manufacturer Narrative
Account updated to verve plastic surgery.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
According to the information retrieved from imedidata on 12/20/2021: procedure type was updated to ¿breast reconstruction primary.¿ manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on december 9, 2022 indicated that the patient encountered infection on the left side on (b)(6) 2022.The issue was resolved.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on august 28, 2023 indicated that secondary procedures was performed on both side.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE¿ TH 610CC
• 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 11754049
• Report Number: 1645337-2021-04748
• Device Sequence Number: 19631353
• Product Code: FTR
• UDI-Device Identifier: 00081317024255
• UDI-Public: 00081317024255
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/09/2021

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: 06/15/2023
• Device Model Number: 3341354
• Device Catalogue Number: 3341354
• Device Lot Number: 7586396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 06/29/2021; 12/20/2021; 01/20/2022; 12/09/2022; 08/28/2023
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 07/20/2021; 12/27/2021; 02/04/2022; 12/20/2022; 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2018
• 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: Required Intervention
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Hispanic
• Patient Race: White