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

Model Number	3543007MC
Medical Device Problem Codes	Gel Leak (1267); Material Rupture (1546)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
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: right rupture and local reaction manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent primary breast augmentation with a 300cc mentor memorygel breast implant on both sides and experienced bilateral swelling, discomfort, and breast implant rupture postoperatively; confirmed via mri.The issue was diagnosed after physical.As a result, the devices were explanted on (b)(6) 2022.This supplemental medwatch report is for the patient¿s right-sided device.
Additional Manufacturer Narrative
On june 21, 2022, mentor became aware of the following and corresponding fields have been updated on this form: - patient is caucasian; fields a5, and a6 have been updated.- date of adverse event was (b)(6) 2022; field b3 has been updated.- date of implant was (b)(6) 2001; field d6a has been updated.On (b)(6) 2022, mentor became aware that patient experienced left side rupture, and right side gel bleed and replacement devices used on (b)(6) 2022 were catalog number 3507300mc; serial number (b)(6) on the left side, and catalog number 3507300mc; serial number (b)(6) on the right side.This supplemental medwatch report is for the patient¿s right-sided device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
As reported under previous follow up number 1, on june 22, 2022, mentor became aware that patient experienced left side rupture, and right side gel bleed and replacement devices used on may 31, 2022 were catalog number 3507300mc; serial number (b)(6) on the left side, and catalog number 3507300mc; serial number (b)(6) on the right side.Corresponding codes have been updated under section h.Reason for device explant and/or reoperation: right gel bleed and local reaction.This supplemental medwatch report is for the patient¿s right-sided device.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 14683095
• Report Number: 1645337-2022-06834
• Device Sequence Number: 17357558
• Product Code: FTR
• UDI-Device Identifier: 00081317004394
• UDI-Public: 00081317004394
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2005
• Device Model Number: 3543007MC
• Device Catalogue Number: 3543007MC
• Device Lot Number: 208028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 06/21/2022; 06/22/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 06/29/2022; 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2000
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White