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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 Device Contamination with Chemical or Other Material
Event Date 11/01/2016
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. Device history record (dhr) review cannot be conducted because no lot number was provided by the customer. (b)(4). The product was not returned to mentor.

 
Event Description

It was reported via mw 5065152 that a female patient underwent a bilateral breast augmentation surgery in (b)(6) of 2013. The product was a silicone gel breast implant. The patient reported to have several undisclosed illnesses within months of getting the implants put in. There is no specific information regarding any diagnoses or symptoms. In (b)(6) of 2016 the implants were explanted and reported to be filled with mold.

 
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Type of DeviceBREAST 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 Key6819201
Report Number1645337-2017-00063
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 11/01/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue NumberUNKNOWN GEL IMPLANT
OTHER Device ID NumberUNKNOWN GEL IMPLANT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2016
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

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