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

Model Number	3341305
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	11/01/2022
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: left late onset 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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 52-year-old female patient underwent revision breast augmentation with 420cc mentor memoryshape breast implant on both sides on (b)(6) 2017 and experienced breast implant rupture on the right side confirmed by mammogram.Additional information related to the event was received on december 2, 2022.According to the information provided the patient developed late onset seroma in both breasts, seroma fluid was collected during bilateral explant surgery, performed on (b)(6) 2022, and sent for cytology.At this time, the results of pathology report have not been provided.Should additional information become available, this case will be re-assessed, notes will be updated, and supplemental report will be submitted.This medwatch report is for the patient¿s left-sided device.
Additional Manufacturer Narrative
On december 13, 2022, the mentor failure analysis lab received the device for evaluation.On december 20, 2022, device evaluation was completed.Device evaluation summary: mentor conducted a visual inspection of the returned device.During the visual evaluation, no apparent damage or visual anomalies were observed on the mentor memoryshape¿ mm+ 420cc returned device.A seroma is a build-up of fluid around the implant.Symptoms from a seroma may include swelling, pain, and bruising.A seroma may occur soon after surgery, or any time later on, which would be referred to as a late seroma.While the body may absorb seromas, some may require surgery for drainage.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.This supplemental report is for the patient¿s left-sided device.Manufacturer¿s reference number: (b)(4).

• Brand Name: ENTOR 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 15960898
• Report Number: 1645337-2022-14949
• Device Sequence Number: 4938630
• Product Code: FTR
• UDI-Device Identifier: 00081317005346
• UDI-Public: 00081317005346
• 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: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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 Expiration Date: 07/26/2021
• Device Model Number: 3341305
• Device Catalogue Number: 3341305
• Device Lot Number: 7356377
• 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: 12/02/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2016
• 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 Age: 52 YR
• Patient Sex: Female