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U.S. Department of Health and Human Services

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

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MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED Back to Search Results
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.
 
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Brand NameMENTOR MEMORYSHAPE BREAST IMPLANT
Type of DevicePROSTHESIS, 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 Key6945114
MDR Text Key89280879
Report Number1645337-2017-00119
Device Sequence Number1
Product Code FTR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P060028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number3541708
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2017
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 Treatment Data
Date Received: 10/12/2017 Patient Sequence Number: 1
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