MAUDE Adverse Event Report: Mentor Texas MENTOR MemoryGel Breast Implant; Prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	3507320MC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint device has been discarded.  as a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.Since no lot number was provided, no manufacturing record evaluation review could be performed.D4: udi: as most of the device characteristics are unknown at this time, the udi is currently not available.Reason for device explant and/or reoperation: seroma.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 patient underwent a breast reconstruction revision surgery with implantation of a 320cc mentor memorygel breast implant prosthesis.Post-operatively, the patient was diagnosed with a right breast seroma.As a result, the patient underwent right-sided exchange with a mentor gel implant on (b)(6) 2024.Follow-ups have been conducted, and no additional information has been received.If more information becomes available, mentor will submit a supplemental report accordingly.

• 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: henry boden ; 3041 skyway circle north; irving, TX 75038 ; +1(949)788-2078
• MDR Report Key: 50091118
• Report Number: 1645337-2026-08587
• Device Sequence Number: 15903526
• Product Code: FTR
• UDI-Device Identifier: 00081317004158
• UDI-Public: 00081317004158
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• 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 Catalogue Number: 3507320MC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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