MAUDE Adverse Event Report: BIMINI HEALTH TECH IDEAL IMPLANT STRUCTURED BREAST IMPLANT; SALINE BREAST IMPLANT

Model Number	47501
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant under investigation.No conclusion at the time of report submission.
Event or Problem Description
Suspected leak of breast implant.It was noticed before it was implanated.

• Brand Name: IDEAL IMPLANT STRUCTURED BREAST IMPLANT
• Common Device Name: SALINE BREAST IMPLANT
• Manufacturer (Section D): BIMINI HEALTH TECH; 420 stevens ave; suite 220; solana beach CA 92075
• Manufacturer Contact: frankie ng ; 420 stevens ave; suite 220; solana beach, CA 92075
• MDR Report Key: 21743662
• Report Number: 3011277972-2025-00054
• Device Sequence Number: 3981515
• Product Code: FWM
• UDI-Device Identifier: 10851795006084
• UDI-Public: 10851795006084
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P120011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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 Model Number: 47501
• Device Catalogue Number: 475CC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Other
• Patient Age: 41 YR
• Patient Sex: Unknown