MAUDE Adverse Event Report: MENTOR TEXAS L.P. MENTOR MEMORYGEL RESTERILIZABLE GEL SIZER; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Model Number	RSZ4754S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
While surgeon/resident placing sizer into breast pocket (using keller funnel), sizer ruptured.Surgeon able to remove sizer material entirely, sizer removed from or table and taken out of service.Sizer was only reprocessed one time.(would typically be good for 10 uses).

• Brand Name: MENTOR MEMORYGEL RESTERILIZABLE GEL SIZER
• Common Device Name: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): MENTOR TEXAS L.P.; 555 airline drive; coppell TX 75019
• MDR Report Key: 11705925
• Report Number: 11705925
• Device Sequence Number: 14452617
• Product Code: MRD
• UDI-Device Identifier: 00081317007838
• UDI-Public: (01)00081317007838
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/13/2021
• Report Date (Section F): 04/13/2021

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 Model Number: RSZ4754S
• Device Catalogue Number: RSZ-4754S
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2021
• Patient Sequence Number: 1
• Patient Age: 52 DA
• Date Report Sent to FDA: 04/13/2021