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

Model Number	3541408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Wrinkling (2613); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2016
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: n/a.(b)(4).
Event or Problem Description
It was reported that a caucasian female patient underwent a breast augmentation with a mentor memoryshape breast implant 440cc and suffered from a bilateral hematoma.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch is for the left breast implant.
Additional Manufacturer Narrative
On (b)(6) 2020, mentor became aware that patient¿s information was erroneously omitted.The weight of the patient was 170 lbs, the height of the patient was 5.5 ft, the patient¿s date of birth is (b)(6) 1977, the patient¿s age was 43-year-old.This event is associated with the glow clinical trial.After clinical/secondary review of this file performed on (b)(6) 2020, it was decided that the hematoma was unilateral (left side).On (b)(6) 2016, the patient presented with hematoma, which required incision, drainage, aspiration.The principal investigator assessed this event as moderate in severity, serious, not related to the device.This medwatch was for the right side.Manufacturer¿s reference number: (b)(4), corrections: the weight of the patient was 170 lbs, the height of the patient was 5.5 ft, the patient¿s date of birth is (b)(4) 1977, the patient¿s age was 43-year-old.
Additional Manufacturer Narrative
On apr 9, 2026, additional information was received indicating the patient experienced bilateral rippling.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 10971572
• Report Number: 1645337-2020-15615
• Device Sequence Number: 11573396
• Product Code: FTR
• UDI-Device Identifier: 00081317005490
• UDI-Public: 00081317005490
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2020

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: 09/30/2018
• Device Model Number: 3541408
• Device Catalogue Number: 3541408
• Device Lot Number: 6755524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 12/09/2020; 04/09/2026
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 12/24/2020; 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White