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

Model Number	3502550
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 6974905
• Report Number: 1645337-2017-00111
• Device Sequence Number: 14655244
• Product Code: FWM
• UDI-Device Identifier: 00081317001485
• UDI-Public: (01)00081317001485(11)170611(17)210610(10)7478626
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1