MAUDE Adverse Event Report: UNKNOWN PROTECTOR, HEARING (INSERT)

Patient Problems Headache (1880); Tinnitus (2103); Sleep Dysfunction (2517); Cognitive Changes (2551)

Event Date 08/15/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, i went to (b)(6) hospital, (b)(6), nm, for an mri requested by (b)(6), hms, my primary care physician.In my ears, the technician inserted two small plastic plug-type items that he said were for ear protection.These devices did not provide adequate protection from the extremely loud noises of the machine - analogous to being attacked with a sonic sledge hammer.As a result of being in the mri machine for the duration of the procedure, i now have debilitating tinnitus in both ears and severe headaches behind the orbital part of my skull.I never had these symptoms before the mri.My hearing, ability to sleep, and cognitive functions have been significantly diminished by this machine.When i called the doctor in charge, he said those ear plugs were fda approved for use in the mri, and therefore it was impossible that i could have experienced these results because the plugs were fda-certified.He refused to acknowledge that i had any physical damage from this machine or the inadequacy of the ear plugs.Subsequently, i read a report about how 3m was recently ordered to pay billions of dollars to the federal government as a result of providing ear plugs for the military that looked similar to the ones he put in my ears, were also fda-approved, but left tens of thousands of soldiers with damaged hearing.I'm concerned because the tinnitus and headaches are very debilitating and other patients are also suffering because (b)(6) hospital's technician refuses to address the issue with its mri device.As far as i know, the mri device is still installed in the hospital and perhaps the type of ear plugs the technician put in my ears are also available.The hospital has a photo of the mri machine.(b)(6) regional medical center.It is not clear from your questions here exactly what kind of information you are seeking nor where it could be found.Reference report: mw5147615.

• Brand Name: PROTECTOR, HEARING (INSERT)
• Type of Device: PROTECTOR, HEARING (INSERT)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18055529
• MDR Text Key: 327488237
• Report Number: MW5147616
• Device Sequence Number: 1
• Product Code: EWD
• Combination Product (y/n): N
• 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: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2023
• Patient Sequence Number: 1
• Treatment: ISOSORBIDE MONO ER.; (B)(6).; (B)(6).; 1/ A.M. 400MG INFLAMMATION.; 1/AM 470MG MOOD SUPPORT.; 1/DAY 1000MCG NERVE AND MUSCLE HEALTH, ; 1/DAY 100MG PREVENT NEUROPATHY.; 1/DAY 500MG PAIN. ; 1/DAY 900MG GLUCOSE METABOLISM.; 1/DAY SEE LIST OF COMPONENTS.; 1/PM 400MG BRAIN AND LIVER HEALTH AND MORE.; 1/PM 470MG.; 2/A.M. 2000MG MYROBALAN.; 2/AM 900MG ENERGY SUPPORT.; 2/DAY 650MG.; 325MG.; ALA 100MG.; ALA.; AMLA ALPHA LIPOIC ACID.; ARBS 100MG.; ASHWAGANDHA EXTRACT.; ASHWAGANDHA EXTRACT.; AT1RECEPTOR BLOCKER.; B6.; BETA BLOCKER ??SIDE EFFECTS 25MG.; BETA BLOCKER ??SIDE EFFECTS 25MG.; BIOTIN.; BLOOD THINNER.; BONE HEALTH ALPHA LIPOIC ACID.; DIABETIC PERIPHERAL NEUROPATHY.; DR. (B)(6). CARVEDILOL.; DR. (B)(6). LOSARTAN.; DR. (B)(6). MAGNESIUM CITRATE.; EVENING - 8:00 CARVEDILOL.; GINSENG COMPLEX.; HELP W/PAIN.; HMS NUTRITIONIST.; JOINT PAIN.; LIVER HEALTH.; METHYL B12.; MOMORDICA CHARANTIA (BITTER MELON).; MOOD SUPPORT TUMERIC.; MUSCLE FUNCTION ECOTRIN ASPIRIN.; OXIDE, 2/DAY 500MG.; PAIN WOMEN'S 50+ MULTIVITAMIN.; PRESCRIPTIONS, OTHER AMT. SERVING PURPOSE W MORNING. 8:30 A.M. ; PREVENT NEUROPATHY.; TRIPHALA.; TURMERIC.; VASODILATOR 15 MG.; VIT D-3 25MCG.; VIT E 45MCG.
• Patient Outcome(s): Disability
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian, Black Or African American, White, American Indian Or Alaskan Native, Native Hawaiian Or Other Pacific Islander