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

Model Number	3341454
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	11/16/2020
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: impaired healing.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a hispanic female patient who underwent breast reconstruction surgery with a 755cc.Mentor memoryshape breast implant experienced left sided delayed wound healing post procedure.As a result, patient had an explantation on a (b)(6) 2020.
Additional Manufacturer Narrative
On december 07, 2022, mentor received additional information.The patient was replaced with a left-sided 610cc mentor memoryshape breast implant on (b)(6) 2022.On december 20, 2022, mentor became aware the patient identifier was not submitted nor was the initial reporter facility name.The appropriate fields have been updated.This report is for the left breast prosthesis.Refer to manufacturing report number 1645337-2022-15238 and 1645337-2022-15235 for the contralateral events.This report is for the left breast prosthesis.Refer to manufacturing report number 1645337-2022-15235 for the contralateral event and manufacturing report number 1645337-2022-15238 for the subsequent left-sided event.Manufacturer¿s reference number: (b)(4).In the initial, a1 patient identifier and e1 initial reporter facility name should have been populated with (b)(6), respectively.

• 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: 11676244
• Report Number: 1645337-2021-04129
• Device Sequence Number: 14356755
• Product Code: FTR
• UDI-Device Identifier: 00081317024279
• UDI-Public: 00081317024279
• 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: 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): 03/18/2021

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: 09/18/2018
• Device Model Number: 3341454
• Device Catalogue Number: 3341454
• Device Lot Number: 7603910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2018
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Hispanic