MAUDE Adverse Event Report: LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Device Problems Electromagnetic Interference (1194); Migration or Expulsion of Device (1395); Vibration (1674)

Patient Problems Shock (2072); Skin Irritation (2076); Foreign Body In Patient (2687)

Event Date 11/08/2017

Event Type  Injury  

Event Description

Retained surgical instrument.Has an electromagnetic incompatibility, or has developed a high electromagnetic potential.The entire environment around me is severely affecting this device.I have been shocked, it vibrates.It's twisting my flesh.It's having burn marks on my skin, it's migrating through my body.The material is breaking up because of the electrical magnetic energy of the forces being put on it.It's coming out through my pores.The top of my head where it's coming out it's turned hard like plastic underneath my scalp causing a bald spot.When i comb it out of my scalp, it feels like sharp pieces of glass and this is going through my entire system.I have had 12 to 14 irradiation events during fluoroscopy imaging.One at the hosp immediately following surgery, and the rest at the orthopedic office.I believe this device interacted with the device left inside my body, the alarms were ignored and it happened enough times to ferromagnetic the device.The device also appears to have a small plate sitting over my chest.Something around neck or partially around neck or in glottis.Tissue reaction with burns last (b)(6) 2018, at orthopedic office which is when it ferromagnetic and i started to completely understand that something was left behind.I've been labeled delusional.And not one professional has tried any safer technique than imaging.I don't think imaging something with electromagnetic incompatibilities was wise, when the properties of the products are not known.Which could be fiber optic after i look at my surgical report.Only one professional has bothered to look at one of the past images taken to see what he could see the device.Without proper investigation of the image, he briefly looked at it and said he didn't see anything wrong.I've been able to not only see it before editing, but was able to pull up more after editing technique can.I was already irradiated and nobody will pull my files and look at them to see what i'm talking about.And i know there are safer ways to verify.Depending on environmental factors, it's sometimes days before i can get into my house.I've spent most of the time outside with a blanket and a heater for almost a year.The combined magnetic energy and will cause some serious issues.I sought emergency help and was put on mental watch.No one here understands the science behind what is happening and i've been labeled instead of investigated and helped.I'm swimming up stream.Is there any one that can help me.Fda safety report id# (b)(4).

• Brand Name: LARYNGOSCOPE
• Type of Device: LARYNGOSCOPE, RIGID
• MDR Report Key: 9322284
• MDR Text Key: 166787570
• Report Number: MW5091086
• Device Sequence Number: 1
• Product Code: CCW
• 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: 11/12/2019

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: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 54