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	11/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Left implant partial deflation.
Additional Manufacturer Narrative
Investigation summary: no leak observed w gently squeezing.Removed valve strap.Filled front (outer lumen) with 10cc of air.Submerged the implant in water, no leak was observed in the back valve.Removed the saline from the implant, filled fully with air the inner and outer lumen.Submerged the implant in water, no leak was observed at the outer shell and both valves.Complaint failure mode was not able to replicated during investigation.

• Brand Name: IDEAL IMPLANT STRUCTURED BREAST IMPLANT
• Common Device Name: SALINE BREAST IMPLANT
• Manufacturer (Section D): BIMINI HEALTH TECH; 420 stevens ave; suite 220; solana beach CA 92075
• Manufacturer (Section G): BIMINI HEALTH TECH; 420 stevens ave; suite 220; solana beach CA 92075
• MDR Report Key: 18323239
• Report Number: 3011277972-2023-00007
• Device Sequence Number: 7026046
• Product Code: FWM
• UDI-Device Identifier: 10851795006046
• UDI-Public: 10851795006046
• 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: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/13/2023

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
• Device Model Number: 33501
• Device Catalogue Number: SIZE 300CC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2022
• 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 Sex: Unknown