MAUDE Adverse Event Report: MENTOR TEXAS MED HEIGHT TE W/SUT TABS 350CC; EXPANDER, SKIN, INFLATABLE

Model Number	3549212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.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: anisomastia.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female who underwent an unknown breast reconstruction surgery with mentor cpx 4 breast tissue expander with suture tabs, 350cc saline breast implant experienced bilateral anisomastia postoperative.As a result, patient underwent bilateral replacements as follow: l/ cat#: 3503754bc, sn#: (b)(4), r/ cat#: 3503754bc, sn#: (b)(4)on (b)(6) 2022.This report relates to one of the two sides.Note: thee devices were received by mentor with some documents.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Additional Manufacturer Narrative
Device evaluation completed on july 05 , 2022: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the med height te w/sut tabs 350cc tissue expander was found to have a tear on the anterior aspect, measuring approximately 0.8 cm.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).

• Brand Name: MED HEIGHT TE W/SUT TABS 350CC
• 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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 14734825
• Report Number: 1645337-2022-07171
• Device Sequence Number: 2350471
• Product Code: LCJ
• UDI-Device Identifier: 00081317006725
• UDI-Public: 00081317006725
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/06/2022

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: 08/22/2025
• Device Model Number: 3549212
• Device Catalogue Number: 3549212
• Device Lot Number: 9616957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/28/2022
• Supplement Date Received by Manufacturer: 06/23/2022; 06/24/2022; 07/05/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 06/27/2022; 06/29/2022; 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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