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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH ROUND HIGH PROFILE SALINE IMPLANTS

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MENTOR MENTOR SMOOTH ROUND HIGH PROFILE SALINE IMPLANTS Back to Search Results
Model Number REF 350-3330
Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250)
Patient Problems Capsular Contracture (1761); Pain (1994); Weight Changes (2607)
Event Date 10/13/2010
Event Type  Injury  
Event Description
My gallbladder had to be removed, due to it working only at 11% after nuclear testing.Severe pain in breasts started in 2016 along with drastic weight loss.An explant surgery on (b)(6) 2017, left was leaking and partially deflated.Right had capsular contracture.
 
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Brand Name
MENTOR SMOOTH ROUND HIGH PROFILE SALINE IMPLANTS
Type of Device
MENTOR SMOOTH ROUND HIGH PROFILE SALINE IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6961135
MDR Text Key89847786
Report NumberMW5072836
Device Sequence Number1
Product Code FWM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/17/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberREF 350-3330
Device Lot Number5840510
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Weight48
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