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

Model Number	3341409
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	12/16/2020
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.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 (b)(6)-year-old caucasian female patient who underwent a revision breast augmentation with two mentor memoryshape breast implant prostheses (left: 555cc, right: 395cc) experienced left-sided seroma and right-sided breast abscess postoperatively.About 4.5 weeks after the implantation day, the patient experienced warm feeling, swelling, and redness in her left breast, and antibiotics were prescribed.However, the patient¿s symptoms did not improve.The diagnosis was confirmed based on physical examination.As a result, the patient underwent bilateral removal without replacement on (b)(6) 2020.Upon explantation, the devices were discarded and are not available for product evaluation.The test results on collected fluids from both breasts indicated moderate white blood cells and no evidence of yeast, fungal, or organism elements.The patient¿s symptoms have been improved after the removal surgery.The event date was estimated as (b)(6) 2020 based on available information.This report is for the left-sided prosthesis.

• 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: 11220227
• Report Number: 1645337-2021-00505
• Device Sequence Number: 5350085
• Product Code: FTR
• UDI-Device Identifier: 00081317005117
• UDI-Public: 00081317005117
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2020

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: 03/19/2022
• Device Model Number: 3341409
• Device Catalogue Number: 3341409
• Device Lot Number: 7443833
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 01/23/2021
• 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: 61 YR