MAUDE Adverse Event Report: MENTOR TEXAS MENTOR TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number	3504307M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	10/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient underwent a primary breast reconstruction with a 550cc mentor tissue expander and experienced a deflation on the left side post-operatively.As a result, the patient underwent explantation on an unspecified date.
Additional Manufacturer Narrative
On may 25, 2023, a photo evaluation for the device was completed.Photo evaluation summary: upon visual evaluation of the image provided in the complaint, the tissue expander appears deflated with a rent in juncture.As the product involved in this complaint was retained, the device couldn´t be analyzed according to our procedures.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Capa activity was not required.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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: deflation.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• 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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 17100852
• Report Number: 1645337-2023-06927
• Device Sequence Number: 1932523
• Product Code: LCJ
• UDI-Device Identifier: 00081317002437
• UDI-Public: 00081317002437
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 04/11/2025
• Device Model Number: 3504307M
• Device Catalogue Number: 3504307M
• Device Lot Number: 9558251
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2021
• 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