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); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
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.Since no lot number was provided, no manufacturing record evaluation could be performed.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 an unspecified surgery with an unknown mentor prosthesis experienced left sided wound infection post procedure.As a result, the implant was explanted on (b)(6) 2021.Note: the type of device involved is unknown, and the gel procode/common device name are being used for submission purposes only.A supplemental report will be submitted if clarifying information is received.
Additional Manufacturer Narrative
Additional information received on may 25, 2022 indicated that the device information is as follow: cat#: 3341354, sn#: (b)(6).The manufacturing record evaluation (mre) was reviewed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.Device implantation date was on (b)(6) 2021.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2022, information through the medidata, showed that they removed the infection on (b)(6) 2021.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Adverse event review clinical note and patient coding verification]: coding was verified on may-08-2024 per 100553403 and 100553401 with the available information about the reportable event.During the 1 year follow up visit (breast-q augmentation (post-operative)) the patient reported dissatisfaction with procedure outcome.At this time, mentor has received very limited information regarding this event, based on the information provided in edc (imedidata) the patient suffered breast asymmetry.It is unclear what side it belongs to.Without clarifying information, ¿ only one side is reported.However, should additional information be received in the future, this file will be updated as needed.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: 12221727
• Report Number: 1645337-2021-08314
• Device Sequence Number: 3621243
• Product Code: FTR
• UDI-Device Identifier: 00081317024255
• UDI-Public: 00081317024255
• 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: 2021
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 06/30/2021

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: 09/16/2025
• Device Model Number: 3341354
• Device Catalogue Number: 3341354
• Device Lot Number: 9491555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 05/25/2022; 07/25/2022; 06/30/2023
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 05/26/2022; 07/28/2022; 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White