MAUDE Adverse Event Report: BIMINI HEALTH TECH PUREGRAFT SERENE 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	11/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Suspected deflation of breast implant.
Additional Manufacturer Narrative
Explant not yet received for analysis.

• 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: frankie ng ; 8400 belleview dr; suite 125; plano, TX 75024
• MDR Report Key: 24043487
• Report Number: 3022978896-2026-00001
• Device Sequence Number: 9010589
• Product Code: FWM
• UDI-Device Identifier: 00850034511689
• UDI-Public: 00850034511689
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P120011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 01/12/2026

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: 44001
• Device Catalogue Number: 440CC
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/12/2026
• 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: 32 YR
• Patient Sex: Female