MAUDE Adverse Event Report: IDEAL IMPLANT INCORPORATED IDEAL IMPLANT STRUCTURED BREAST IMPLANT; SALINE-FILLED BREAST IMPLANT

Model Number	37001
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Alleged deflation.
Event or Problem Description
Deflation.
Additional Manufacturer Narrative
Macroscopic and microscopic examination of the explanted device revealed outer shell tear due to damage during assembly causing outer lumen deflation.

• Brand Name: IDEAL IMPLANT STRUCTURED BREAST IMPLANT
• Common Device Name: SALINE-FILLED BREAST IMPLANT
• Manufacturer (Section D): IDEAL IMPLANT INCORPORATED; 14881 quorum drive; suite 925; dallas TX 75254
• Manufacturer (Section G): VESTA INC; 9900 south 57 street; franklin WI 53132
• Manufacturer Contact: robert hamas ; 14881 quorum drive; suite 925; dallas, TX 75254
• MDR Report Key: 16855927
• Report Number: 3011491947-2023-00161
• Device Sequence Number: 7648003
• Product Code: FWM
• UDI-Device Identifier: 10851795006053
• UDI-Public: (01)10851795006053(241)37001(17)211105
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2021
• Device Model Number: 37001
• Device Catalogue Number: 370
• Device Lot Number: 653219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2018
• 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: 42 YR
• Patient Sex: Female