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

Model Number	59501
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Alleged deflation.
Additional Manufacturer Narrative
No manufacturing defect or other abnormality was found on macroscopic or microscopic examination of the explanted device.No leak could be reproduced during explant analysis.A diagnostic error occurred.Updates/corrections made to sections: b1, b2, b4, b5, d6b, d9, g3, g6, h2, h3, h6, h10.
Event or Problem Description
Deflation resulting in explantation.

• Brand Name: IDEAL IMPLANT STRUCTURED BREAST IMPLANT
• Common Device Name: SALINE-FILLED BREAST IMPLANT
• MDR Report Key: 12104540
• Report Number: 3011491947-2021-00174
• Device Sequence Number: 17188492
• Product Code: FWM
• UDI-Device Identifier: 10851795006114
• UDI-Public: (01)10851795006114(241)59501(17)200328
• 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: 2017
• Device Explanted Year: 2021
• 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): 06/30/2021

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: 03/28/2020
• Device Model Number: 59501
• Device Catalogue Number: 595
• Device Lot Number: 61935
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 10/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2017
• 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: 34 YR