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

Model Number	RSZ3001S
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: na.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female who underwent an unknown breast surgery used a mentor memorygel resterilizable gel sizer 300cc mgel sizer experienced discoloration of the device before the procedure.The physician stated that the sizer was in contact with the patient but the patient wasn't in the operating room to provide any more information.The physician indicated that the gel sizer starting to turn a different color.First it was like a tan light golden color once it was opened from the packaging then after sterilizing it's a different color and he just wants to know if he can use it again and if the color is normal.No further information was provided regarding this case.Should more information become available, this case will be re-assessed and notes will be updated.
Additional Manufacturer Narrative
On (b)(6) 2020, mentor became aware of submitting unreportable event to fda unintentionally in previous initial report.Please see the details in h.11.Manufacturer¿s reference number: (b)(4) this product: ( mentor memorygel resterilizable gel sizer 300cc mge) is not classified as a medical device, therefore not subject to fda mdr reporting regulations.

• Brand Name: MENTOR MEMORYGEL RESTERILIZABLE GEL SIZER
• Common Device Name: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10936254
• Report Number: 1645337-2020-15342
• Device Sequence Number: 3317386
• Product Code: MRD
• UDI-Device Identifier: 00081317007524
• UDI-Public: 00081317007524
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020

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: 09/05/2021
• Device Model Number: RSZ3001S
• Device Catalogue Number: RSZ3001S
• Device Lot Number: 7373787
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR