MAUDE Adverse Event Report: ESTABLISHMENT LABS S.A. MOTIVA IMPLANTS; Prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	ERSD-320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Usa.Allegedly, the patient required removal of the right breast implant at the end of october due to development of a hematoma.Implant replacement is planned for (b)(6), 2026.The investigation is in progress.
Additional Manufacturer Narrative
As stated in the literature: "hematoma significantly increased the risk of contracture (handel, et al.2006)".¿breast hematoma is one complication in which the risk factors remain unknown.Hematomas frequently present within the first week after surgery, with significant pain and breast enlargement.Breast hematomas may acutely become large enough to warrant surgical drainage and hemostasis.¿ (collins, & verheyden, 2012)".Per our directions for use, each patient must receive the establishment labs s.A.¿motiva implants®: information for the patient¿ during her surgical consultation, it is the surgeons´ responsibility to ensure that the patient completely understands the information regarding the risks, benefits, and recommendations associated with silicone gel-filled breast implant surgery, as well as the complications typical of any type of surgery.This document is available in motiva® website: ifu.Motiva.Health the instructions for use in the directions for use were reviewed, to determinate if there are indications that ensure the prevention and good handling of the product.For this event, it is considered that the information is suitable for the section of surgical precautions as follows: "a hematoma is a collection of blood within the breast tissue.Hematomas are one of the several complications that may follow a breast-augmentation procedure.Symptoms of hematomas generally include swelling, bruising and pain around the incision area.While most hematomas are small and will completely drain on their own and the blood re-absorbs into the body, those patients that are experiencing moderate to severe pain should undergo a follow-up visit.Most hematomas will either resolve on their own or will only require draining.Drains are small surgical tubes that lead out of the breast with a small bulb attached to collect blood and other fluids".In addition, a review of the device history record was conducted, and it was concluded that there were no deviations in the manufacturing process of this device that would have caused or contributed to this incident.

• Brand Name: MOTIVA IMPLANTS
• Common Device Name: Prosthesis, breast, noninflatable, internal, silicone gel-filled
• 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 ; 8003554164
• MDR Report Key: 24215927
• Report Number: 3012883202-2026-01823
• Device Sequence Number: 8392493
• Product Code: FTR
• UDI-Device Identifier: 07445161010575
• UDI-Public: (01)07445161010575(11)250304(17)300304
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

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: Lay User/Patient
• Device Catalogue Number: ERSD-320
• Device Lot Number: 25022887
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• 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: Required Intervention
• Patient Sex: Unknown