MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE¿ TH 545CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341304
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, 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: infection.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
This event is associated with the glow clinical trial.It was reported that a female patient who underwent breast reconstruction primary surgery with mentor glow study gel devices on (b)(6) 2020.Adverse event # 1.Infection, (right side, implant serial number: (b)(4).Doi: (b)(6) 2020, doe: (b)(6) 2020).On (b)(6) 2020, she presented with infection, which required implant removal.The principal investigator assessed this event as severe in severity, serious, possibly related to the device, and related to the procedure.The device was replaced with cat#: 3505004bc, sn#: (b)(4).Adverse event # 2.Infection, (left side, implant serial number: (b)(4).Doi: (b)(6) 2020, doe: (b)(6) 2020.On (b)(6) 2020, she presented with infection, which required implant removal.The principal investigator assessed this event as severe in severity, serious, possibly related to the device, and related to the procedure.The device was replaced with cat#: 3505004bc, sn#: (b)(4).Should more information become available, this note will be updated and case reassessed.This report relates to the left prosthesis.
Additional Manufacturer Narrative
According to the information retrieved from imedidata on december 2,2021: -procedure type was updated to ¿breast reconstruction primary¿.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE¿ TH 545CC
• 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: 11924611
• Report Number: 1645337-2021-06157
• Device Sequence Number: 847796
• Product Code: FTR
• UDI-Device Identifier: 00081317024248
• UDI-Public: 00081317024248
• 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
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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: 09/24/2024
• Device Model Number: 3341304
• Device Catalogue Number: 3341304
• Device Lot Number: 9363791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2019
• 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 Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White