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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SM ROUND MOD PLUS PROFILE SALINE

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MENTOR SM ROUND MOD PLUS PROFILE SALINE Back to Search Results
Model Number 350-2225
Event Type  Injury  
Event Description

Breast implants thought to be cause of health problems. After having the implants started having problems with angioedema, idiopathic anaphylaxis, edema, hives. Never had problems before implants.

 
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Brand NameSM ROUND MOD PLUS PROFILE SALINE
Type of DeviceSM ROUND MOD PLUS PROFILE SALINE
Manufacturer (Section D)
MENTOR
MDR Report Key6363917
Report NumberMW5068156
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 02/25/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received02/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number350-2225
Device LOT Number5684289
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?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/25/2017 Patient Sequence Number: 1
Treatment
EPI-PEN
MAGNESIUM OCCASIONALLY.
OTC MEDS: VITAMIN D3 OCCASIONALLY
POTASSIUM
PREDNISONE OCCASIONALLY.
PROBIOTICS OCCASIONALLY.
RX MEDS: FUROSEMIDE
SPIRONOLACTONE
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