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

Model Number 33501

Device Problem Insufficient Information (3190)

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

Event Date 05/30/2023

Event Type  Injury  

Event Description

Alleged 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; 343 franklin rd; suite 108; brentwood TN 37027
• Manufacturer Contact: robert hamas ; 14881 quorum drive; suite 925; dallas, TX 75254 ; 2144922500
• MDR Report Key: 17132171
• MDR Text Key: 317203003
• Report Number: 3011491947-2023-00195
• Device Sequence Number: 1
• Product Code: FWM
• UDI-Device Identifier: 10851795006046
• UDI-Public: (01)10851795006046(241)33501(17)240804
• 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
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 33501
• Device Catalogue Number: 335
• Device Lot Number: 63621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/16/2021
• 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: 33 YR
• Patient Sex: Female