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

Catalog Number	3507425MC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	06/12/2024
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.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.Reason for device explant and/or reoperation: hematoma.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a breast augmentation surgery with implantation of a 425cc mentor memorygel breast implant prosthesis.Post-operatively, the patient was diagnosed with a hematoma of the left breast by a medical professional.As a result, the patient underwent breast implant removal on (b)(6) 2024.
Additional Manufacturer Narrative
On august 07, 2024, mentor completed an evaluation on an image that was provided of the suspect medical device.Upon visual evaluation of the image provided in the complaint no apparent damage or visual anomalies were observed.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On september 03, 2024, the mentor analysis lab received the suspect medical device for evaluation.Paperwork received with the device provided a patient identifier.Patient identifier: (b)(6).On september 11, 2024, mentor completed an evaluation on the returned device.Mentor conducted a visual inspection of the device.During visual evaluation no apparent damage or visual anomalies were observed on the breast implant device.Hematoma is a collection of blood within the space around the implant.Symptoms from hematoma may include swelling, pain, and bruising.If a hematoma occurs, it will most likely occur soon after surgery; however, it can occur at anytime, such as after an injury to the breast.Small hematomas may be absorbed by the body, while others may require surgery for drainage.Hematoma is a known complication associated with this procedure and is referenced in our product insert data sheet.Manufacturer¿s reference number: (b)(4).

• 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 19912063
• Report Number: 1645337-2024-09117
• Device Sequence Number: 8867249
• Product Code: FTR
• UDI-Device Identifier: 00081317004202
• UDI-Public: (01)00081317004202(11)230504(17)280502(10)9901436
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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 Catalogue Number: 3507425MC
• Device Lot Number: 9901436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 08/07/2024; 09/03/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 08/22/2024; 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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