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

Model Number 21001

Device Problems Insufficient Information (3190); Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2023

Event Type  Injury  

Event Description

Alleged deflation.

Event Description

Alleged deflation.

Manufacturer Narrative

No manufacturing defect was found on macroscopic or microscopic examination of the explanted device.Explant analysis showed surgical instrument damage of the implant outer shell which resulted in outer lumen deflation.

• Brand Name: IDEAL IMPLANT STRUCTURED BREAST IMPLANT
• Type of Device: 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: 16441131
• MDR Text Key: 310221199
• Report Number: 3011491947-2023-00063
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

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 Operator: Health Professional
• Device Expiration Date: 09/16/2022
• Device Model Number: 21001
• Device Catalogue Number: 210
• Device Lot Number: 695540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 02/26/2023
• Supplement Dates Manufacturer Received: 06/02/2023
• Supplement Dates FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female