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

Catalog Number 3541708

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seroma (2069); No Code Available (3191); Anaplastic Large Cell Lymphoma (3264)

Event Date 06/06/2017

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.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(4).

Event Description

It was reported via fda medwatch (form #mw5072020) that a patient who underwent primary breast reconstruction for cancer was diagnosed with bia-alcl.The patient underwent implantation with a mentor memoryshape gel breast implant on (b)(6) 2015.The patient developed fluid around the right breast.There was an evaluation conducted on the implant fluid, and the diagnosis of bia-alcl was made on (b)(6) 2017.On (b)(6) 2017, the implant and the capsule were removed.There was no contact information provided, therefore no follow up was completed and there is no additional information available.

• Brand Name: MENTOR MEMORYSHAPE 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: joaquin kurz ; 3041 skyway circle north; irving, TX 75038 ; 949789-383
• MDR Report Key: 6945114
• MDR Text Key: 89280879
• Report Number: 1645337-2017-00119
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Health Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3541708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening; Required Intervention