MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number 3545455

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

The product investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.The device history record (dhr) of lot number 7374907 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.(b)(4).

Event Description

It was reported that memorygel siltex round ultra high 455c (p/n: 3545455; l/n: 7374907-027) had a piece of fiber on it and it did not appear sterile.

Manufacturer Narrative

Device evaluation results: it was reported that memorygel siltex round ultra high 455c (p/n: 3545455; l/n: 7374907-027) had a piece of fiber on it and it did not appear sterile.Upon receipt at mentor, the device contained clear fluid and weighed 462.7 grams.No foreign material was observed within the device, nor on the shell surface.The device was found to be intact.No anomalies were observed.Mentor performs 100% inspection and testing of all devices prior to release, including inspections for surface imperfections and foreign materials in/on the shell.The customer complaint could not be confirmed.Manufacturer¿s ref.No: (b)(4).Legacy manufacturer's ref.(b)(4).

Event Description

It was reported that memorygel siltex round ultra high 455c (p/n: 3545455; l/n: 7374907-027) had a piece of fiber on it and it did not appear sterile.

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• Manufacturer (Section G): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• Manufacturer Contact: joaquin kurz ; north irving, TX 75038-3540 ; 9497893837
• MDR Report Key: 6810708
• MDR Text Key: 83244256
• Report Number: 1645337-2017-00057
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• PMA/PMN Number: P030053
• 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,Followup
• Report Date: 11/18/2016

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: 09/11/2021
• Device Catalogue Number: 3545455
• Device Lot Number: 7374907
• Other Device ID Number: 3545455
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 08/22/2017
• Supplement Dates Manufacturer Received: 11/18/2016
• Supplement Dates FDA Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2016
• 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 Age: 37 YR