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	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient reported deflation, received no info about the surgeon.
Event or Problem Description
Patient reported deflation, received no info about the surgeon.

• 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: 20488908
• Report Number: 3011277972-2024-00050
• Device Sequence Number: 14352729
• Product Code: FWM
• UDI-Device Identifier: 10851795006077
• UDI-Public: 10851795006077
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P120011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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
• Operator of Device: Health Professional
• Device Model Number: 44001
• Device Catalogue Number: 440CC
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female