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

Model Number	24001
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Suspected deflation of breast implant.
Additional Manufacturer Narrative
Explant not yet received for analysis.
Event or Problem Description
Suspected deflation of breast implant.
Additional Manufacturer Narrative
The investigation identified delamination of the patch in the inner shell.Based on the evaluation of the returned product and available information, the most likely root cause was a manufacturing defect.

• Brand Name: PUREGRAFT SERENE 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: gladys paez fonseca ; 8400 belleview dr.; plano, TX 75024 ; 9403442223
• MDR Report Key: 24501891
• Report Number: 3022978896-2026-00003
• Device Sequence Number: 13247582
• Product Code: FWM
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P120011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 24001
• Device Catalogue Number: 240CC
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 06/10/2026
• 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 Age: 39 YR
• Patient Sex: Female