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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANT

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MENTOR SALINE BREAST IMPLANT Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Fatigue (1849); Arthralgia (2355); Cognitive Changes (2551)
Event Date 04/01/2009
Event Type  Injury  
Event Description
Insidious health problems increasing in severity over a four year period after breast implant procedure to include; debilitating fatigue, chronic and debilitating joint pain, and cognitive dysfunction.
 
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Brand Name
SALINE BREAST IMPLANT
Type of Device
SALINE BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6566553
MDR Text Key75242397
Report NumberMW5069759
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 05/11/2017
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 Received05/11/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
COLOSTRUM; MAGNESIUM; MONOLAURIN; OTC MEDS: VITAMIN D; PROBIOTICS; RX MEDS: FLORINEF; TRAMADOL; VITAMIN C
Patient Outcome(s) Disability;
Patient Age40 YR
Patient Weight64
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