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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SALINE TEXTURED BREAST IMPLANT; SALINE BREAST IMPLANTS

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MENTOR MENTOR SALINE TEXTURED BREAST IMPLANT; SALINE BREAST IMPLANTS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Congenital Defect/Deformity (1782); Pain (1994); Swelling (2091); Electrolyte Imbalance (2196)
Event Date 04/01/2007
Event Type  Injury  
Event Description
My child was born when i had breast implants and was diagnosed with sensory integration disorders.Pain, swallowing issues, skin issues, high calcium, low potassium, high copper, leg pains, breast implant illness symptoms.Severe gut pains, bone pains, swelling in hands, stiffness in legs.
 
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Brand Name
MENTOR SALINE TEXTURED BREAST IMPLANT
Type of Device
SALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6976765
MDR Text Key90226557
Report NumberMW5072945
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 10/24/2017
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/25/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
CASTOR OIL PACKS; MAGNESIUM BATHS; OTC MEDS: PROBIOTICS; RX MEDS: NONE.
Patient Outcome(s) Other; Required Intervention;
Patient Age9 YR
Patient Weight29
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