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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

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MENTOR WORLDWIDE LLC; BREAST IMPLANT Back to Search Results
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.
 
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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 Key6494780
MDR Text Key72876708
Report Number1645337-2017-00029
Device Sequence Number1
Product Code FTR
Combination Product (y/n)N
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN GEL IMPLANT
Other Device ID NumberUNKNOWN GEL IMPLANT
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/14/2017
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 N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age43 YR
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