MAUDE Adverse Event Report: MENTOR CORPORATION MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Model Number 300CC

Device Problem Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/31/2016

Event Type  malfunction  

Event Description

Breast implant sizer dispensed to sterile field.During placement of the sizer into the left breast,the sizer ruptured.Ruptured sizer was removed from the field.A second sizer was dispensed to the sterile field.During placement of the second sizer into the right breast, the sizer ruptured.The ruptured sizer was removed from the field.

• Brand Name: MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER
• Type of Device: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): MENTOR CORPORATION; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 6099270
• MDR Text Key: 59765443
• Report Number: 6099270
• Device Sequence Number: 1
• Product Code: MRD
• 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: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 300CC
• Device Catalogue Number: RSZ-3001S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR