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

Model Number 3507400BC

Device Problem Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 01/28/2020

Event Type  Injury  

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: the patient has not undergone explantation or reoperation at this time.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a (b)(6) year old caucasian female patient who underwent a breast augmentation revision with two 400cc smooth mentor memorygel breast implant has experienced postoperative bilateral rupture of implants.Rupture was confirmed by mri.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch report is for the left-sided implant.

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Type of Device: 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 ; 949789-868
• MDR Report Key: 9772618
• MDR Text Key: 181561518
• Report Number: 1645337-2020-03352
• Device Sequence Number: 1
• Product Code: FTR
• UDI-Device Identifier: 00081317000136
• UDI-Public: 00081317000136
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2012
• Device Model Number: 3507400BC
• Device Catalogue Number: 3507400BC
• Device Lot Number: 5743806
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 02/29/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/23/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR