MAUDE Adverse Event Report: MENTOR TEXAS L.P. MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number 3503751BC

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2017

Event Type  malfunction  

Event Description

During a bilateral breast augmentation, the implant that was to be used for the right breast was discovered to have/contain foreign material.The implant packaging was opened and inspected on the sterile field table in the or.The surgeon noticed a piece of plastic that was attached to the outside of the shell.Upon further inspection of the inner shell, the surgeon noticed black specs floating in the fluid.The implant was removed from the field and a new implant was used for the procedure.The device was given to the manufacturer representative by the or staff for further investigation.No harm came to the patient.Manufacturer requested implant and packaging directly from or team to investigate.

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS L.P.; 3041 skyway cir n.; irving TX 75038
• MDR Report Key: 6666640
• MDR Text Key: 78381233
• Report Number: 6666640
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/01/2018
• Device Model Number: 3503751BC
• Device Catalogue Number: 3503751BC
• Device Lot Number: 6726311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Age: 45 YR
• Patient Weight: 58