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

Model Number	3543007MC
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient underwent revision breast augmentation with 275cc mentor memorygel breast implant on the right side, and with 300cc mentor memorygel breast implant on the left (date of implant: (b)(6) 2014) and experienced breast implant rupture on the right side complicated by granuloma formation in the right axilla region confirmed by biopsy performed during surgery.It was also reported that the patient developed capsular contracture; baker grade ii on the left, and baker grade iii on the right.It was also reported that the patient developed late onset seroma, the fluid was sent for pathology, at this time, the results of the pathology report have not been provided.As a result, the patient underwent bilateral explantation and replacement with bilateral new saline implants on (b)(6) 2022.This medwatch report is for the patient¿s left-sided device.
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: left late onset seroma, and capsular contracture; baker grade ii.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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 13472411
• Report Number: 1645337-2022-01269
• Device Sequence Number: 4826127
• Product Code: FTR
• UDI-Device Identifier: 00081317004394
• UDI-Public: 00081317004394
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 09/30/2016
• Device Model Number: 3543007MC
• Device Catalogue Number: 3543007MC
• Device Lot Number: 6509634
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2011
• 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: 50 YR
• Patient Sex: Female