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

Model Number	44001
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Supplemental report is being submitted to correct the number of events summarized to a single event.Each individual event will have its own associated medwatch form 3500a.
Event or Problem Description
Partial deflation of right side implant with a changed appearance.

• 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: 21108254
• Report Number: 3011277972-2025-00013
• Device Sequence Number: 20850009
• Product Code: FWM
• UDI-Device Identifier: 00850034511689
• UDI-Public: 00850034511689
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P120011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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
• Device Model Number: 44001
• Device Catalogue Number: 440CC
• Device Lot Number: 0110425
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (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: Female