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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR TEXAS UNKNOWN SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

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MENTOR TEXAS UNKNOWN SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE Back to Search Results
Catalog Number UNKNOWN SALINE IMPLANT
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2013
Event Type  Injury  
Manufacturer Narrative

At the time of this report, mentor has received no information regarding explantation or an expected explantation date. It is unknown at this time if the device will be made available for return. As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made. As such, the investigation will be closed. If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate. Since no lot number was provided, no device history record (dhr) review could be performed. (b)(4).

 
Event Description

It was reported (via fda medwatch) that a female patient of unknown age who underwent breast prostheses implantation with mentor saline implants on (b)(6) 2000 experienced the following: "in 2000 i got mentor spectrum adjustable implants; 5 years ago i started getting sick. I'm getting worse. I was healthy prior to 5 years ago, currently show autoimmune symptoms with neg blood work. Hair falling out, weight gain, lymph nodes swollen, breast pain left side. Bruising on body, brain fog, joint muscle chronic pain, body swollen, use walker or cane. Headaches, fevers, fatigue, urinate on myself avg 5 times a day. Ibs, osteoporosis, told i have lupus and ra, but negative blood work. Low white blood count. Depression, asthma, hard time breathing at times. I want to get the implants taken out, but can't afford to do so. " no product issue, such as rupture, was reported. No date of revision or explantation was reported. This report is for the right implant.

 
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Brand NameUNKNOWN SALINE IMPLANT
Type of DevicePROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Manufacturer (Section D)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
Manufacturer (Section G)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
Manufacturer Contact
gabriel alfageme
3041 skyway circle north
irving , TX 75038
949789-868
MDR Report Key8023320
Report Number1645337-2018-06496
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 10/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/31/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN SALINE 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 Received11/16/2018
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/31/2018 Patient Sequence Number: 1
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