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

Catalog Number	RSF-550+
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Unspecified Immune System Problem (4435); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Usa.Patient allegedly developed a systemic immune response following breast revision surgery.Treating physicians reportedly considered the presentation consistent with possible mast cell activation.Patient was undergoing evaluation and treatment in the emergency department at the time of reporting.No further information was provided at this time.
Additional Manufacturer Narrative
Breast implants are no different from any foreign material implanted into the human body, and can trigger a host's protective immune reaction.It is a foreign body response demonstrated by redness, swelling, warmth, pain, and or/loss of function.\ \ a comprehensive review of the device history record (dhr) for the affected lot was completed.No deviations, non-conformances, or anomalies were identified during manufacturing.All raw materials and process parameters conformed to specified quality requirements.

• 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
• Manufacturer Contact: susana hidalgo ; building b-25, coyol free zone; alajuela,alajuela 20113 ; +1(800)355-4164
• MDR Report Key: 50862351
• Report Number: 3012883202-2026-02931
• Device Sequence Number: 10053385
• Product Code: FTR
• UDI-Device Identifier: 07445161002167
• UDI-Public: (01)07445161002167(11)250804(17)300804
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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-550+
• Device Lot Number: 25072783
• 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: 08/28/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2025
• 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: Hospitalization
• Patient Sex: Unknown