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

Model Number 40501

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2017

Event Type  malfunction  

Event Description

Inadequate valve strap bond.

Manufacturer Narrative

The evaluation summary is as follows: macroscopic and microscopic examination of the explanted device revealed inadequate anterior valve strap bond to the implant shell.Device was not implanted.

Event Description

Deflation resulting in explantation.

• Brand Name: IDEAL IMPLANT STRUCTURED BREAST IMPLANT
• Type of Device: SALINE-FILLED BREAST IMPLANT
• Manufacturer (Section D): IDEAL IMPLANT; 14881 quorum drive; suite 925; dallas TX 75254
• Manufacturer (Section G): SPECIALTY SILICONE FABRICATORS, INC.; 2761 walnut avenue; tustin CA 92780
• Manufacturer Contact: stacey brown ; 14881 quorum drive; suite 925; dallas, TX 75254 ; 2144922500
• MDR Report Key: 6323773
• MDR Text Key: 67383164
• Report Number: 3011491947-2017-00006
• Device Sequence Number: 1
• Product Code: FWM
• UDI-Device Identifier: 10851795006060
• UDI-Public: (01)10851795006060(241)40501(17)180601
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: 40501
• Device Catalogue Number: 405
• Device Lot Number: 61193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention