MAUDE Adverse Event Report: Mentor Texas SMOOTH MOD HIGH BOOST, 330 CC; Prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	SMHB330
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2026
Type of Reportable Event	Malfunction

• Brand Name: SMOOTH MOD HIGH BOOST, 330 CC
• 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: henry boden ; 3041 skyway circle north; irving, TX 75038 ; +1(949)788-2078
• MDR Report Key: 50916482
• Report Number: 1645337-2026-10444
• Device Sequence Number: 5369801
• Product Code: FTR
• UDI-Device Identifier: 10081317031250
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• 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: SMHB330
• Device Lot Number: 2196787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2026
• 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