MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PLUS PROFILE; BREAST IMPLANT

Model Number 3502550

Device Problem Component Missing (2306)

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

Event Date 09/21/2017

Event Type  malfunction  

Manufacturer Narrative

The product is implanted.As a result, no product failure analysis can be conducted and device malfunction cannot be confirmed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer's ref.No: (b)(4).

Event Description

It was reported by a physician¿s office that a mentor smooth round moderate plus profile saline device was received without the fill valve.Per the contact, there was no significant procedural delay, and the procedure was completed with a fill valve that the hospital had available.No additional procedure was required, and no adverse event resulted from this incident.

• Brand Name: MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: joaquin kurz ; 3041 skyway circle north; irving, TX 75038 ; 949789-383
• MDR Report Key: 6974905
• MDR Text Key: 90785427
• Report Number: 1645337-2017-00111
• Device Sequence Number: 1
• Product Code: FWM
• UDI-Device Identifier: 00081317001485
• UDI-Public: (01)00081317001485(11)170611(17)210610(10)7478626
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2021
• Device Model Number: 3502550
• Device Catalogue Number: 3502550
• Device Lot Number: 7478626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/11/2017
• 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