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

Model Number	63501
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Deflation resulting in explantation.
Additional Manufacturer Narrative
The following updates were made to the report: report type, date of this report, manufacturer name, city and state, contact office - name/address/phone number, type of report, type of reportable event, if follow-up, what type, unchecked evaluation summary attached, event problem and evaluation codes, and additional narratives/data.Evaluation summary was removed as an attachment.The evaluation summary is as follows: no manufacturing defect was found on macroscopic or microscopic examination of the explanted device.Explant analysis showed surgical instrument damage of the implant outer shell which resulted in outer lumen deflation.
Event or Problem Description
Deflation resulting in explantation.

• 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: 7487237
• Report Number: 3011491947-2018-00008
• Device Sequence Number: 19186535
• Product Code: FWM
• UDI-Device Identifier: 10851795006121
• UDI-Public: (01)10851795006121(241)63501(17)181113
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P120011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2018
• Device Model Number: 63501
• Device Catalogue Number: 635
• Device Lot Number: 61399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 04/16/2019
• 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: 41 YR