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

Model Number	3541508
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	12/07/2020
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: seroma.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a caucasian female underwent breast augmentation with 530cc mentor memoryshape breast implants and experienced bilateral seroma postoperatively.As a result, the patient underwent bilateral drainage on (b)(6) 2020.This report is for the patient's right-sided device.
Additional Manufacturer Narrative
Additional information: on (b)(6) 2021, mentor became aware that the patient also experienced rupture on the left side.As a result, the patient underwent unilateral device removal and replacement with a 680cc mentor memorygel breast implant, catalog number 3341509, serial number (b)(6), on the left side on (b)(6) 2021.Mentor also became aware of the correct date of birth, the patient identifier and the patient's age at the time of event.This report is for the patient's right-sided device.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Additional information: on april 29, 2021, mentor became aware that the patient also experienced device migration on the left side.This report is for the patient's right-sided device.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
• MDR Report Key: 11136357
• Report Number: 1645337-2021-00231
• Device Sequence Number: 11727130
• Product Code: FTR
• UDI-Device Identifier: 00081317005513
• UDI-Public: 00081317005513
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2020

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: 03/10/2022
• Device Model Number: 3541508
• Device Catalogue Number: 3541508
• Device Lot Number: 7440677
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 03/25/2021; 04/29/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 04/14/2021; 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR