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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SALINE HIGH PROFILE IMPLANTS
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MENTOR SALINE HIGH PROFILE IMPLANTS Back to Search Results
Health Effect - Clinical Codes Fatigue (1849); Muscle Weakness/Atrophy (1967); Toxicity (2333); Fungal Infection (2419); Ambulation or Postural Difficulties (2544); Cognitive Changes (2551)
Date of Event 03/01/2004
Type of Reportable Event Serious Injury
Event or Problem Description
Mold chest wall infection from defective implants with leaking valves.Developed mold and debris inside of implants.Toxins poisoned my body.I developed a mold chest wall infection.My muscles became so weak that i am now in a wheelchair.Other issues such as vision problems and constant fatigue.Loss of fine motor skills.Explant (b)(6) 2016.Product defect (leaking valves - mentor saline high profile).Batches of mentor saline implants from 2004 and 2004 had leaking valves.Mold chest wall infection.Toxins leaking out so extensive that it put me in a wheelchair.All of the above on surgical report.
 
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Brand Name
SALINE HIGH PROFILE IMPLANTS
Common Device Name
SALINE HIGH PROFILE IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6150759
Report NumberMW5066563
Device Sequence Number15841419
Product Code FWM
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2016
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 12/05/2016
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/05/2016
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
FISH OIL; OTC MEDS: MULTIVITAMIN; RX MEDS: NA
Outcome Attributed to Adverse Event Disability;
Patient Age34 YR
Patient Weight66
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