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

Model Number	3547007
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Autoimmune Reaction (1733); Capsular Contracture (1761); No Code Available (3191); Cancer (3262)
Date of Event	01/01/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.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: neoplasm malignant , rupture , capsular contracture, autoimmune disorder.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient underwent a breast augmentation primary with a mentor memorygel breast implant 700cc and suffered from autoimmune disorder (guillain-barre syndrome ) , bilateral rupture and melanoma, breast pain on the right breast implant, capsular contracture on the left implant.As a result, the patient had undergone removal and replacement with mentor memorygel breast implant 425cc on (b)(6) 2013.This medwatch is for the left breast implant.

• 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
• MDR Report Key: 10215635
• Report Number: 1645337-2020-08074
• Device Sequence Number: 3271259
• Product Code: FTR
• UDI-Device Identifier: 00081317000761
• UDI-Public: 00081317000761
• 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: 1999
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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: 02/29/2004
• Device Model Number: 3547007
• Device Catalogue Number: 3547007
• Device Lot Number: 189042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR