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

Catalog Number	3543607MC
Medical Device Problem Codes	Material Discolored (1170); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun, but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.No lot number was reported.However, two devices with lot numbers 6465352 & 7355161 were received.A device history record review is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent an unspecified procedure with a mentor memorygel breast implant 360cc.The device was reported as ¿cloudy or delaminating¿ upon visual examination by the physician.As a result, the patient underwent bilateral removal and replacement with mentor memorygel breast implant 790cc, catalog number shpx-790, serial number (b)(4), lot number 7629623 (l) and mentor memorygel breast implant 450cc, catalog number 3504501bc, serial number (b)(4), lot number 7611062 (r) on (b)(6) 2018.
Additional Manufacturer Narrative
On 1/28/2019, a manufacturing record evaluation (mre) was reviewed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.Device evaluation summary: manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 6/10/2019, it was noticed that the follow-up type for the supplemental report 1645337-2019-07790 submitted on 2/22/2019 was incorrect.The correct follow-up type is additional information.The device evaluation is in progress.
Additional Manufacturer Narrative
Device evaluation summary: during evaluation of the device, the gel contained was observed clear, bubbles were found in the device and the shell surface appears without damage.No other anomalies were discovered.The second product received is related to a concomitant device, therefore no further investigation is required.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.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
• MDR Report Key: 8279670
• Report Number: 1645337-2019-07790
• Device Sequence Number: 13875951
• Product Code: FTR
• UDI-Device Identifier: 00081317004424
• UDI-Public: 00081317004424
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/26/2018

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: 04/30/2016
• Device Catalogue Number: 3543607MC
• Device Lot Number: 6465352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 01/28/2019; 06/10/2019; 07/10/2019
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 02/22/2019; 06/10/2019; 07/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR