MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE¿ TH 680CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341404
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Post Operative Wound Infection (2446)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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: na.(b)(4).If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturers reference number: (b)(4).
Event or Problem Description
It was reported that a caucasian female who underwent breast augmentation revision with a mentor memoryshape 680cc silicone prosthesis experienced left sided seroma post procedure.As a result, doctor performed incision for the drainage, and the issue was resolved.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On (b)(6) 2021 additional information received indicated that the patient experienced left sided seroma on (b)(6) 2021, she had bactrim, and unspecified secondary procedure and the issue was resolved, then another episode of seroma on (b)(6) 2021, which the implant was removed and replaced.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, mentor became aware that the initial reporter: ( manufacturer report number 1645337-2021-01181, has typo error on d2b section.On (b)(6) 2021, additional information received indicated that due to wound infection on the left side, patient had the left implant replaced with another implant with cat#: 3451234, sn#: (b)(6), on (b)(6) 2021.Manufacturer¿s reference number: (b)(4).2b.Procode: ftr.
Additional Manufacturer Narrative
On june 28, 2021 mentor became aware that unintentionally missed reporting patients¿ weight and identifier in initial report.Manufacturer¿s reference number: (b)(4).A4 patient weight: 135 lb, and a1 patient identifier: (b)(6).
Additional Manufacturer Narrative
Per additional information received on october 20, 2022 patient had another onset of seroma on (b)(6) 2021.Patient underwent, secondary procedure on (b)(6) 2020, which resolved the issue.Memoryshape catalog number: 334-1404 serial number: (b)(6), catalog number: 334-1404 serial number: (b)(6).Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE¿ TH 680CC
• 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: 11287684
• Report Number: 1645337-2021-01181
• Device Sequence Number: 3846087
• Product Code: FTR
• UDI-Device Identifier: 00081317024262
• UDI-Public: 00081317024262
• 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: Other,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/15/2021

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: 08/28/2025
• Device Model Number: 3341404
• Device Catalogue Number: 3341404
• Device Lot Number: 9491403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 02/08/2021; 03/09/2021; 06/28/2021; 10/20/2022
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 02/22/2021; 03/10/2021; 07/02/2021; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2020
• 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 Age: 44 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White