MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE¿ MM 775CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3541708
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Autoimmune Disorder (1732); Capsular Contracture (1761); Seroma (2069)
Date of Event	12/01/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint device has been retained by the customer, 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, rupture, cap con unknown grade.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient who underwent a breast reconstruction revision with two 775cc mentor memoryshape, silicone breast implant has experienced bilateral ruptures, capsular contractures unknown grades, and unexplained systemic symptoms postoperatively, including seroma, pneumothrorax, sunken chest -sjogrens, raynauds, ibs, asthma, and other autoimmune disorders.The patient reported that at the time of the removal of the implant, doctor punctured her lung and caused the pneumothorax.The patient also reported that she went to 35 different doctors in arizona and tested for everything that the doctors prescribed, the result indicated that she didn't have autoimmune hepatitis, it was dermatomyositis which meant she had to take the implants out.As a result, patient underwent bilateral removal without replacement on (b)(6) 2017.This report relates to the right prosthesis.
Additional Manufacturer Narrative
On january 12, 2022, mentors' clinician advised that per correct codification to remove the patient code "seroma".Manufacturer¿s reference number: (b)(4) removal of patient code seroma.

• Brand Name: MENTOR MEMORYSHAPE¿ MM 775CC
• 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: 13180345
• Report Number: 1645337-2022-00209
• Device Sequence Number: 12196026
• Product Code: FTR
• UDI-Device Identifier: 00081317005537
• UDI-Public: 00081317005537
• 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: 2013
• Device Explanted Year: 2017
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 3541708
• Device Catalogue Number: 3541708
• Device Lot Number: 6766791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2013
• 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: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White