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

Model Number	33501
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This submission was previously made under: 3011277972-2025-00057 on may 1, 2025 with a typographical error of 3011277972-2025-00027, causing the submission to fail due to a duplicate report number.From a microscopic analysis of the implant, it showed a crescent shaped puncture of 4.07 mm.The shape and size of the puncture suggests needle damage.The investigation revealed a tiny puncture in the outer lumen of the left implant.
Event or Problem Description
Suspected right implant deflation.

• Brand Name: IDEAL IMPLANT STRUCTURED BREAST IMPLANT
• Common Device Name: SALINE BREAST IMPLANT
• Manufacturer (Section D): BIMINI HEALTH TECH; 8400 belleview dr; suite 125; plano TX 75024
• Manufacturer Contact: frankie ng ; 8400 belleview dr; suite 125; plano, TX 75024
• MDR Report Key: 24240558
• Report Number: 3022978896-2026-00002
• Device Sequence Number: 8971318
• Product Code: FWM
• UDI-Device Identifier: 10851795006046
• UDI-Public: 10851795006046
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 2025
• 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): 02/02/2026

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 Model Number: 33501
• Device Catalogue Number: 335CC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 02/02/2026
• 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: Other; Required Intervention
• Patient Sex: Unknown