MAUDE Adverse Event Report: Mentor Texas MENTOR Tissue Expander; Expander, skin, inflatable

Catalog Number	3504305M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction

• 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): Perouse Plastie; 1 rue camille desmoulins; issy les moulineaux ; FR
• Manufacturer Contact: henry boden ; 3041 skyway circle north; irving, TX 75038 ; +1(949)788-2078
• MDR Report Key: 50848308
• Report Number: 1645337-2026-10496
• Device Sequence Number: 9936016
• Product Code: LCJ
• UDI-Device Identifier: 00081317002413
• UDI-Public: (01)00081317002413(17)280528(10)9988645
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3504305M
• Device Lot Number: 9988645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2024
• 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
• Patient Sex: Unknown