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

Model Number	3341254
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Hematoma (1884); Seroma (2069); Post Operative Wound Infection (2446); Wrinkling (2613)
Date of Event	09/22/2020
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: rippling, asymmetry, implant malposition, hematoma, and early onset seroma.Manufacturers reference number: (b)(4).
Event or Problem Description
This event is in relation to (b)(6) study participant (b)(6).It was reported that a caucasian female patient who underwent breast reconstruction surgery with a 485cc mentor memoryshape breast implant experienced left sided rippling, asymmetry, implant malposition, hematoma, and early onset seroma post procedure.On (b)(6) 2020, patient underwent a surgical intervention to have acellular dermal graft placement, fat grafting, flap reconstruction to address the rippling, asymmetry and implant malposition.On (b)(6) 2020, patient had drainage and aspiration to address the hematoma.As a result of the early onset seroma, patient underwent removal and replacement with an unspecified breast implant on (b)(6)2021.
Additional Manufacturer Narrative
On (b)(6) 2021, mentor became aware that patient experienced primary breast reconstruction surgery.Manufacturer¿s reference number:(b)(4).
Additional Manufacturer Narrative
On january 20, 2022, mentor became aware that patient also experienced a wound infection post procedure.Subject id: (b)(6).This event is associated with the glow clinical trial.Reason for device explant and/or reoperation: rippling, asymmetry, implant malposition, hematoma, early onset seroma, wound infection.Manufacturer¿s reference number: (b)(4).

• 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
• 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: 11943796
• Report Number: 1645337-2021-06326
• Device Sequence Number: 11818900
• Product Code: FTR
• UDI-Device Identifier: 00081317024231
• UDI-Public: 00081317024231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2025
• Device Model Number: 3341254
• Device Catalogue Number: 3341254
• Device Lot Number: 9433628
• 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: 05/14/2021
• Supplement Date Received by Manufacturer: 11/30/2021; 01/20/2022
• Initial Report FDA Received Date: 06/05/2021
• Supplement Report FDA Received Date: 12/26/2021; 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2020
• 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: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White