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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 350-1680
Device Problems Material Rupture (1546); Defective Component (2292); Device Contamination with Chemical or Other Material (2944)
Patient Problems Pain (1994); Swollen Lymph Nodes (2093); Fungal Infection (2419); No Code Available (3191)
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.Manufacturer's ref.No: (b)(4).
 
Event Description
It was reported that a female patient underwent a breast augmentation surgery using mentor saline smooth round moderate profile implants on (b)(6) 2003.The patient suffered sternal pain, mastodynia and mold infection manifested as enlarged lymph nodes, and was diagnosed bio-toxin disease in 2015.The implants were removed surgically on (b)(6) 2015 and found to have defective valves, internal debris and determined to have been leaking. .
 
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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
carl hansen
north irving, TX 75038-3540
9497893858
MDR Report Key6643555
MDR Text Key77645930
Report Number1645337-2017-00038
Device Sequence Number1
Product Code FWM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 05/18/2017
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? Yes
Device Operator Health Professional
Device Catalogue Number350-1680
Device Lot NumberUNKNOWN
Other Device ID Number350-1680
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/18/2017
Initial Date FDA Received06/15/2017
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
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