MAUDE Adverse Event Report: Establishment Labs S.A. MOTIVA IMPLANTS; SmoothSilk Plus

Catalog Number	RSD-320+
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: SmoothSilk Plus
• Manufacturer (Section D): Establishment Labs S.A.; building b-25, coyol free zone; alajuela,alajuela 20113 ; CS 20113
• Manufacturer (Section G): Establishment Labs S.A.; building b-25, coyol free zone; alajuela,alajuela 20113 ; CS 20113
• Manufacturer Contact: susana hidalgo ; building b-25, coyol free zone; alajuela,alajuela 20113 ; CS 20113 ; +1(800)355-4164
• MDR Report Key: 50657001
• Report Number: 3012883202-2026-02881
• Device Sequence Number: 10445646
• Product Code: FTR
• UDI-Device Identifier: 07445161001917
• UDI-Public: (01)07445161001917(11)250114(17)300114
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2026

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 Catalogue Number: RSD-320+
• Device Lot Number: 25010461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown