MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number UNKNOWN GEL IMPLANT

Device Problem Material Rupture (1546)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swollen Lymph Nodes (2093); No Code Available (3191)

Event Date 01/31/2017

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.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.(b)(4).The product is not returned.

Event Description

It was reported that the patient has suffered bodily injury and resulting pain and suffering, disability, mental anguish, loss of capacity for the enjoyment of life, hospitalization, medical and nursing care and treatment, loss of ability to earn money in the future.Patient also had developed rashes and pruritis.Dermatologist and allergist were seen without relief.The patient sought treatment from several physicians, who concluded that the implants were responsible for patient¿s condition.The patient had the implants surgically removed on (b)(6) 2017, at which time the surgeon noted that the implants were leaking.Pathological evaluation of the patient¿s lymph nodes, removed during the explantation surgery, revealed reactive histiocytosis which is associated with silicone leaking from the prostheses.

• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• Manufacturer (Section G): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• Manufacturer Contact: carl hansen ; north irving, TX 75038-3540 ; 9497893858
• MDR Report Key: 6749011
• MDR Text Key: 81229031
• Report Number: 1645337-2017-00046
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN GEL IMPLANT
• Device Lot Number: UNKNOWN
• Other Device ID Number: UNKNOWN GEL IMPLANT
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention