MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE¿ MM+ 650CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3341505
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Granuloma (1876); No Code Available (3191)
Date of Event	02/20/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medwatch number: mw5081704.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.Since no lot number was provided, no manufacturing record evaluation (mre)) review could be performed.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
A patient has reported that underwent a breast surgery reconstruction procedure with mentor¿s breast implants (b)(4) has developed capsular contracture associated with breast implant the patients has also reported unexplained systemic symptoms, which included but not limited to fatigue, anxiety depression, stress, muscular and joint pain, , neurasthenia, paraesthesia, hair loss, , memory loss, fever, sweating, sleeping disorder, mental concentration impaired cognitive and dermatological symptoms.No further information is available at this time.Should more information become available, this case will be re-assessed and notes will be updated.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report is for the left side,.
Additional Manufacturer Narrative
It was reported on march 19, 2024, through medwatch number: mw5081704 that the patient also experienced breast implant rupture bilaterally complicated by multiple granuloma formation.As a result, the patient underwent bilateral explantation on (b)(6) 2024.Reason for device explant and/or reoperation: generalized illnesses, rupture, capsular contracture unknown grade, and granuloma.Should additional information become available, this case will be re-assessed and notes will be updated.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE¿ MM+ 650CC
• 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 ; 949789-8687
• MDR Report Key: 8438354
• Report Number: 1645337-2019-09529
• Device Sequence Number: 16212706
• Product Code: FTR
• UDI-Device Identifier: 00081317005384
• UDI-Public: 00081317005384
• Combination Product (Y/N): N
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3341505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown