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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 350-3250
Medical Device Problem Codes Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Autoimmune Disorder (1732); No Code Available (3191)
Date of Event 02/23/2015
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
It was reported that a (b)(6) female patient underwent bilateral breast prostheses implantation with mentor saline implants on (b)(6) 2005.Patient presented with bilateral implant deflation with defective valves.She also reported mold, fungus and bio-toxins were leaking into her body.Patient had implants explanted on (b)(6) 2014.No further information was obtained.
 
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Common Device Name
BREAST IMPLANT
Manufacturer (Section D)
MENTOR WORLDWIDE LLC
3041 skyway circle
north irving TX 75038 3540
MDR Report Key6498500
Report Number1645337-2017-00033
Device Sequence Number1580181
Product Code FWM
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2005
Device Explanted Year2014
Reporter Type Manufacturer
Report Source consumer
Type of Report Initial
Report Date (Section B) 02/23/2015
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
Operator of Device Health Professional
Device Catalogue Number350-3250
Device Lot Number5610526-045
Other Device ID Number350-3250
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/17/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age56 YR
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