MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number UNKNOWN GEL IMPLANT

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

Patient Problems Pain (1994); Cognitive Changes (2551)

Event Date 12/01/2016

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.(b)(4).The device was not returned to mentor.

Event Description

It was reported that (b)(6) the female patient underwent primary breast augmentation surgery using mentor gel implants in 2000.Patient suffered pain on the left side for the past year and it was getting worse.She also had memory problems, fogginess, tinnitus on the left side, headache, joint pain, cold.Her face started to swell when she got cold.Patient was scheduled to have mri exam later.No further information was available.No reports of rupture or other product issues.

• 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: joaquin kurz ; north irving, TX 75038-3540 ; 9497893837
• MDR Report Key: 6494780
• MDR Text Key: 72876708
• Report Number: 1645337-2017-00029
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• 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: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN GEL IMPLANT
• Other Device ID Number: UNKNOWN GEL IMPLANT
• Is the Reporter a Health Professional?: Yes
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR