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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 SALINE IMPLANT
Device Problems Defective Component; Device Contamination with Chemical or Other Material
Event Date 06/19/2017
Event Type  Injury  
Manufacturer Narrative

This complaint was reported via medwatch form # mdr mw5070517 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 the no lot number was provided by the customer. (b)(4). The product is not returned.

 
Event Description

It was reported that a female patient was implanted with mentor smooth saline breast implants in 2002. She stated that her immune system was getting worse since implantation as she experienced autoimmune symptoms. She also reports headaches, brain fog, joint pain, body aches, chronic fatigue, dry eyes, weight loss, digestive system issues, sore feet, and increased recovery period from any surgery. She claimed that the implants were removed in 2016. The implants were found with faulty valves and mold. She also claimed that the implants caused harm to her children during pregnancy and breastfeeding as her children's immune system were over-reactive to everything.

 
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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
carl hansen
north irving , TX 75038-3540
9497893858
MDR Report Key6786582
Report Number1645337-2017-00050
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 07/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/10/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN SALINE IMPLANT
OTHER Device ID NumberUNKNOWN SALINE IMPLANT
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2017
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 Initial

Patient TREATMENT DATA
Date Received: 08/10/2017 Patient Sequence Number: 1
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