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

Catalog Number	RSZHPB480S
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
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 a non-conformance was identified related to device malfunction.This non-conformance will be addressed through mentor¿s quality system.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 480cc mentor memorygel boost resterilizable gel sizer was observed to have a labeling discrepancy regarding the catalog number.One side of the device indicated the sizer was to be used to size for smpb catalogs while the other side indicated the sizer itself was a sizer for shpb catalogs.
Additional Manufacturer Narrative
On august 26, 2024, mentor completed an evaluation on an image that was provided of the suspect medical device.Upon visual evaluation of the images provided in the complaint, a discrepancy was observed between the profile stamp in the anterior view and the one on the posterior view.Based on the information currently available, a notification was sent to mentor's manufacturing team for further investigation.In conclusion, per the evaluation performed and data records reviewed on the complaint device, the stamp/incorrect mark on the pad printing side on this product complaint is confirmed to be a manufacturing defect.In addition, corrective actions will be implemented as part of a capa and a product issue escalation (pie) process to ensure this issue does not reoccur.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BOOST RESTERILIZABLE GEL SIZER
• Common Device Name: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 19629047
• Report Number: 1645337-2024-07754
• Device Sequence Number: 8610111
• Product Code: MRD
• UDI-Device Identifier: 00081317027461
• UDI-Public: 00081317027461
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Catalogue Number: RSZHPB480S
• Device Lot Number: 9988856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown