MAUDE Adverse Event Report: MENTOR MENTOR; SMOOTH ROUND HIGH PROFILE GEL

Model Number 350-3754BC

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

Patient Problems Chest Pain (1776); Dry Eye(s) (1814); Dyspnea (1816); Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Increased Sensitivity (2065); Swelling (2091); Burning Sensation (2146); Tingling (2171); Dizziness (2194); Arthralgia (2355); Impaired Healing (2378); Sore Throat (2396)

Event Date 05/05/2014

Event Type  Injury  

Event Description

Dry eyes (difficulty crying) dry mouth (always thirsty) dry throat (difficulty swallowing pills, food gets stuck) gel hoarse, especially in evenings.Painful joints (most hands, knees, hips, shoulders) bone pain swelling of hands, tight skin.Difficulty sleeping, difficulty recalling words (mixing up words), short term memory issues.Fatigue pressure on face (under eyes, around nose) constant headaches, tingling in hands and feet (fall asleep, drop things, difficulty opening things, typing etc).Stomach issues: burning in lower abdomen, reflux heart races, chest pains, (stabbing pain , both sides).Shortness of breath (feel like i can't catch my breath).Constant lower back pain (and right hip).Extreme smell sensitivity and intolerance of foods i used to eat.Difficulty healing (wound etc.) dizziness (light headedness).

• Brand Name: MENTOR
• Type of Device: SMOOTH ROUND HIGH PROFILE GEL
• Manufacturer (Section D): MENTOR; goleta CA 93117
• MDR Report Key: 6989871
• MDR Text Key: 90758469
• Report Number: MW5073035
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017
• 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: Lay User/Patient
• Device Expiration Date: 03/24/2024
• Device Model Number: 350-3754BC
• Device Lot Number: 6524088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 48 YR
• Patient Weight: 50