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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
Medical Device Problem Code Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 11/01/2016
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.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 or Problem 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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Common Device Name
BREAST IMPLANT
Manufacturer (Section D)
MENTOR WORLDWIDE LLC
3041 skyway circle
north irving TX 75038 3540
MDR Report Key6819201
Report Number1645337-2017-00063
Device Sequence Number90337
Product Code FTR
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2016
Reporter Type Manufacturer
Report Source other
Type of Report Initial
Report Date (Section B) 11/01/2016
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? Yes
Operator of Device Lay User/Patient
Device Catalogue NumberUNKNOWN GEL IMPLANT
Other Device ID NumberUNKNOWN GEL IMPLANT
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/01/2016
Initial Report FDA Received Date08/24/2017
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;
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