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

Model Number	370CC
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant not yet received for analysis.
Event or Problem Description
Suspected breast implant deflation.

• Brand Name: PUREGRAFT SERENE 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: 23367276
• Report Number: 3022978896-2025-00061
• Device Sequence Number: 9931482
• Product Code: FWM
• UDI-Device Identifier: 00850034511641
• UDI-Public: 00850034511641
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 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): 10/23/2025

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: 370CC
• Device Catalogue Number: 370CC
• 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: 10/21/2025
• Initial Report FDA Received Date: 10/23/2025
• 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; Other
• Patient Age: 65 YR
• Patient Sex: Unknown