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

Model Number 40501

Device Problems Material Perforation (2205); Insufficient Information (3190)

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

Event Date 02/08/2023

Event Type  Injury  

Event Description

Alleged deflation.

Manufacturer Narrative

Macroscopic and microscopic examination of the explanted device revealed a minute particle of cured silicone within the shell causing outer shell failure and deflation.

Event Description

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): TRELLEBORG SEALING SOLUTIONS; 2761 walnut avenue; tustin CA 92780
• Manufacturer Contact: robert hamas ; 14881 quorum drive; suite 925; dallas, TX 75254
• MDR Report Key: 16464381
• MDR Text Key: 310488331
• Report Number: 3011491947-2023-00071
• Device Sequence Number: 1
• Product Code: FWM
• UDI-Device Identifier: 10851795006060
• UDI-Public: (01)10851795006060(241)40501(17)240604
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 40501
• Device Catalogue Number: 405
• Device Lot Number: 63510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2021
• 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: 42 YR
• Patient Sex: Female