MAUDE Adverse Event Report: Bimini Health Tech IDEAL STRUCTURED BREAST IMPLANT; Saline Breast Implant

Model Number	55501
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Deflation (4061)
Health Effect - Clinical Codes	Failure of Implant (1924); Breast Discomfort/Pain (4504)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient has a history of anxiety attacks which led her to have to visit a cardiologist in (b)(6) 2026.During this visit, the doctor took x-rays and discovered that her left implant had ruptured.She is otherwise healthy, she is just experiencing pain and discomfort from ruptured implant.
Event or Problem Description
Patient has a history of anxiety attacks which led her to have to visit a cardiologist in (b)(6) 2026.During this visit, the doctor took x-rays and discovered that her left implant had ruptured.She is otherwise healthy, she is just experiencing pain and discomfort from ruptured implant.Additional information received 09/28/2026 - the surgery took place on 9/11/26.During the procedure, we discovered the implant was not ruptured.
Additional Manufacturer Narrative
Additional information received from the clinic stated that the device was not actually deflated/ruptured.

• Brand Name: IDEAL STRUCTURED BREAST IMPLANT
• Common Device Name: Saline Breast Implant
• Manufacturer (Section D): Bimini Health Tech; 8400 belleview dr; ste 125; plano TX 75024
• Manufacturer Contact: mallory stevenson ; 8400 belleview dr; ste 125; plano, TX 75024 ; +1(858)348-8050
• MDR Report Key: 50308248
• Report Number: 3022978896-2026-00041
• Device Sequence Number: 10672353
• Product Code: FWM
• UDI-Device Identifier: 10851795006107
• UDI-Public: 10851795006107
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P120011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: Health Professional
• Device Model Number: 55501
• Device Catalogue Number: 555cc
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 68 YR
• Patient Sex: Female