MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH ROUND AND MODERATE PROFILE SALINE SALINE BREAST IMPLANTS

Model Number 350-1655

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Dyspnea (1816); Fainting (1847); Fatigue (1849); Hair Loss (1877); Headache (1880); Inflammation (1932); Memory Loss/Impairment (1958); Muscle Weakness (1967); Nausea (1970); Pain (1994); Tinnitus (2103); Hot Flashes/Flushes (2153); Tingling (2171); Myalgia (2238); Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361); Neck Pain (2433); Sweating (2444); Palpitations (2467); Sleep Dysfunction (2517); Weight Changes (2607)

Event Date 06/10/2005

Event Type  Injury  

Event Description

I became very ill, diagnosed with fibromyalgia, capsular contra (grade 3 and 4) many symptoms to include; chronic body pain, breast pain, chronic fatigue, hair loss, muscle, joint weakness and pain, ringing in ears, ibs, insomnia, anxiety, depression, tingling and pins and needles in hands and feet, headaches, weight gain, food intolerances, shoulder, neck, back, arms, hands, leg and foot pain, heart palpitations, shortness of breath, inflammation, diagnosed with fibromyalgia and arthritis, breast tumors and cysts. Shortness of breath, night sweats and hot flashes, nausea, lightheadedness, brain fog, poor concentration. Unable to work.

• Brand Name: MENTOR SMOOTH ROUND AND MODERATE PROFILE SALINE
• Type of Device: SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6529987
• Report Number: MW5069435
• Device Sequence Number: 1
• Product Code: FWM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/26/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 350-1655
• Device Lot Number: 5595588
• 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 Age: 50 YR
• Patient Weight: 79
• Patient Treatment(s): CYCLOBENZAPRINE; EPSILON SALT BATHS.; ESTRADIOL; IBUPROFEN. ; INDOMETHACIN; MULTIVITAMIN; OMEGA 3; OTC MEDS: VITAMIN D; OXYCODONE; PROBIOTICS; PROPRANOLOL; PROZAC; RX MEDS: LOSARTIN; TRAZADONE; TUMERIC; TYLENOL; VITAMIN B12; VITAMIN C; WOMEN'S DAILY; XANAX
• Patient Outcome(s): Disability