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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
Device Problems Contamination (1120); Material Disintegration (1177); Fluid/Blood Leak (1250); Defective Component (2292)
Patient Problems Fatigue (1849); Muscle Weakness (1967); Toxicity (2333); Fungal Infection (2419); Ambulation Difficulties (2544); Cognitive Changes (2551)
Event Date 03/01/2004
Event Type  Injury  
Event 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 NameSALINE HIGH PROFILE IMPLANTS
Type of DeviceSALINE HIGH PROFILE IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6150759
Report NumberMW5066563
Device Sequence Number1
Product Code FWM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/05/2016
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage
Patient Weight66
Patient Treatment(s)
FISH OIL; OTC MEDS: MULTIVITAMIN; RX MEDS: NA
Patient Outcome(s) Disability;
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