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

Model Number	59501
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Alleged deflation.

• 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: 10833361
• Report Number: 3011491947-2020-00317
• Device Sequence Number: 3526363
• Product Code: FWM
• UDI-Device Identifier: 10851795006114
• UDI-Public: (01)10851795006114(241)59501(17)181113
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P120011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2018
• Device Model Number: 59501
• Device Catalogue Number: 595
• Device Lot Number: 61481
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR