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

Model Number 30001

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

Surgical intervention took place on (b)(6) 2020 to correct malpositioning of implant.No device defect was reported and device was not explanted.

Event Description

Surgical intervention required for malpositioning.

• 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
• Manufacturer (Section G): VESTA, INC.; 9900 s 57th st; franklin, wi
• Manufacturer Contact: robert hamas ; 14881 quorum drive; suite 925; dallas, tx ; 4922500
• MDR Report Key: 10237743
• MDR Text Key: 197736539
• Report Number: 3011491947-2020-00211
• Device Sequence Number: 1
• Product Code: FWM
• UDI-Device Identifier: 10851795006039
• UDI-Public: (01)10851795006039(241)30001(17)220128
• 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
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2022
• Device Model Number: 30001
• Device Catalogue Number: 300
• Device Lot Number: 661868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2019
• 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
• Patient Age: 37 YR