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

Model Number	63501
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/31/2018
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: date of this report, contact office - name/address/phone number, type of report, 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.Debris/tissue was observed in the valve channel, which likely disrupted the seal, causing a leak and 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: 8450243
• Report Number: 3011491947-2019-00080
• Device Sequence Number: 1147734
• Product Code: FWM
• UDI-Device Identifier: 10851795006121
• UDI-Public: (01)10851795006121(241)63501(17)200715
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2020
• Device Model Number: 63501
• Device Catalogue Number: 635
• Device Lot Number: 62185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2019
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 05/23/2019
• 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: 49 YR