MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT

Catalog Number 3504001BC

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 02/17/2017

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record (dhr) review is in progress.Once completed, the information will be submitted in a supplemental.(b)(4).

Event Description

It was reported that a (b)(6) female patient underwent breast augmentation revision with mentor gel device on (b)(6) 2011.She experienced breast asymmetry (the right breast was lower than the left breast) on (b)(6) 2011, so the patient underwent a revision procedure on (b)(6) 2017 in (b)(6).During this procedure, the surgeon noted that the right breast was discolored (brown).Per patient, the physician woke her up in the middle of the procedure informing her of the discoloration and asked her if he could replace them, therefore the patient underwent bilateral replacement.The patient believes that the discoloration is a fungus growth inside the right device.Per patient, the physician believes the right device was defective.The patient did not report any other symptoms and did not want to return the devices back for failure analysis.Physician did not perform any pathology tests.The left device was not discolored.No deflation were found on both devices.

Manufacturer Narrative

The device history record (dhr) review for this device was completed on 10/12/2017.The manufacturing and expiration dates of the device were also made available, as a result, the manufacturing date, expiration date and udi fields have been updated.The device history record (dhr) of lot number 6472266 was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).

Manufacturer Narrative

Device analysis: since the product was not returned for evaluation no product failure analysis can be conducted, and no determination of possible contributing factors could be made.No related complaints were found for this lot number.If the product is received in the future the investigation will continue.The device history record (dhr) of lot number 6472266 was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.There are multiple controls within the manufacturing process.At multiple points the devices are processed to ensure any foreign matter, particulates or contaminants are removed or 100% visually inspected for any defects including foreign matter or particulates and subsequently rejected when identified.The application failure modes and effects analysis (afmea) was reviewed for the defect in question (foreign matter/mold) with the hazard risk was determined to be as low as possible (alap), with no further action required.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: joaquin kurz ; 3041 skyway circle north; irving, TX 75038 ; 650687-492
• MDR Report Key: 6906512
• MDR Text Key: 87847517
• Report Number: 1645337-2017-00110
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• 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,Followup,Followup
• Report Date: 08/31/2017

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: 05/31/2016
• Device Catalogue Number: 3504001BC
• Device Lot Number: 6472266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/31/2017
• Initial Date FDA Received: 09/29/2017
• Supplement Dates Manufacturer Received: 08/31/2017; 03/25/2019
• Supplement Dates FDA Received: 11/07/2017; 04/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR