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

Model Number	59501
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dr.Confirmed capsule contracture baker grade 3.
Event or Problem Description
Capsule contracture.

• Brand Name: IDEAL IMPLANT STRUCTURED BREAST IMPLANT
• Common Device Name: SALINE-FILLED BREAST IMPLANT
• Manufacturer (Section D): IDEAL IMPLANT; 14881 quorum drive; suite 925; dallas TX 75254
• MDR Report Key: 9679552
• Report Number: 3011491947-2020-00105
• Device Sequence Number: 16811151
• Product Code: FWM
• UDI-Device Identifier: 10851795006114
• UDI-Public: (01)10851795006114(241)59501(17)201218
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2020

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: 01/23/2020
• Initial Report FDA Received Date: 02/06/2020
• 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: 46 YR