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

Model Number	59501
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	06/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Physician statement: doctor confirmed capsule contracture on the left side.
Event or Problem Description
Capsule contracture.
Event or Problem Description
Capsule contracture.
Additional Manufacturer Narrative
Capsule contracture was reported as the reason for explantation.Update and/or corrections to the following sections: b4, d4, d7, g7, h2, h3, h6, and h10.

• Brand Name: IDEAL IMPLANT STRUCTURED IMPLANT
• Common Device Name: SALINE-FILLED BREAST IMPLANT,
• Manufacturer (Section D): IDEAL IMPLANT INCORPORATED; 14881 quorum drive; suite 925; dallas, tx TX 75254
• MDR Report Key: 9267478
• Report Number: 3011491947-2019-00220
• Device Sequence Number: 2615709
• Product Code: FWM
• UDI-Device Identifier: 10851795006114
• UDI-Public: (01)10851795006114(241)59501(17)201218
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P120011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2020

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: 12/18/2020
• Device Model Number: 59501
• Device Catalogue Number: 595
• Device Lot Number: 62513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 02/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR