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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR TEXAS L.P. MENTOR SMOOTH ROUND MODERATE PLUS PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
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MENTOR TEXAS L.P. MENTOR SMOOTH ROUND MODERATE PLUS PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE Back to Search Results
Model Number 3502375D
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/03/2026
Type of Reportable Event Malfunction
Event or Problem Description
After opening the breast implant the cst [certified surgical technologist] noticed a small black hair inside the implant package.The implant was not used and removed from the field.
 
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Brand Name
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
Common Device Name
PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Manufacturer (Section D)
MENTOR TEXAS L.P.
555 airline drive
coppell TX 75019
MDR Report Key25485021
Report Number25485021
Device Sequence Number9930446
Product Code FWM
UDI-Device Identifier10081317028731
UDI-Public(01)10081317028731
Combination Product (Y/N)N
Initial Reporter StateFL
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type User Facility
Initial Reporter Occupation Risk Manager
Type of Report Initial
Report Date (Section B) 06/11/2026
Report Date (Section F) 06/11/2026
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 Model Number3502375D
Device Catalogue Number350-2375D
Device Lot Number2175624
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location Hospital
Date Report to Manufacturer06/12/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/12/2026
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age34 YR
Patient SexFemale
Patient Weight63 KG
Date Report Sent to FDA06/11/2026
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