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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANTS

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MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANTS Back to Search Results
Model Number 350-1460
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cellulitis (1768)
Event Date 06/27/2016
Event Type  Injury  
Event Description
I developed reoccurring breast cellulitis due to 10 year old saline breast implants.
 
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Brand Name
SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANTS
Type of Device
BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6260478
MDR Text Key65313781
Report NumberMW5067289
Device Sequence Number2
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 01/15/2017
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
Device Operator No Information
Device Model Number350-1460
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/15/2017
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age38 YR
Patient Weight86
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