MAUDE Adverse Event Report: Establishment Labs S.A. MOTIVA IMPLANTS; SilkSurface Plus with Qid

Catalog Number	RSF-295+Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ptosis (2620); Physical Asymmetry (4573)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: SilkSurface Plus with Qid
• 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
• Manufacturer Contact: susana hidalgo ; building b-25, coyol free zone; alajuela,alajuela 20113 ; +1(800)355-4164
• MDR Report Key: 50213851
• Report Number: 3012883202-2026-02753
• Device Sequence Number: 9998548
• Product Code: FTR
• UDI-Device Identifier: 07445161002877
• UDI-Public: (01)07445161002877(11)230119(17)280119
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: RSF-295+Q
• Device Lot Number: 23011177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown