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

Model Number	3546007
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Local Reaction (2035); Deformity/ Disfigurement (2360)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: biopsy to rule out cancer, fluid aspiration.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a primary breast augmentation procedure with a mentor memorygel breast implant 600cc gel breast prosthesis that ruptured post implantation.Rupture of the patient¿s right breast prosthesis was reported.Additionally, a biopsy was performed to rule out cancer and fluid was aspirated.Pathology results are still pending.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
Correction: after clinical/secondary review of this file performed on 28-jan-2022, it was decided to add h6 health effect - clinical code e040203 ¿local reaction¿ to more accurately capture the reported event.Manufacturer¿s reference number: (b)(4).H6 health effect - clinical code: local reaction (e040203).

• 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 13227781
• Report Number: 1645337-2022-00327
• Device Sequence Number: 3919460
• Product Code: FTR
• UDI-Device Identifier: 00081317000754
• UDI-Public: 00081317000754
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2011
• Device Model Number: 3546007
• Device Catalogue Number: 3546007
• Device Lot Number: 5687009
• 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: 12/22/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2006
• 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: 32 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White