MAUDE Adverse Event Report: KLS MARTIN MANUFACTURING, LLC PLT BNE MAXILLO 2H MIC STR LN ; PLATE, FIXATION, BONE

Model Number 25-302-13-09

Device Problem Electromagnetic Interference (1194)

Patient Problems Hypersensitivity/Allergic reaction (1907); Tachycardia (2095); Burning Sensation (2146); Radiation Exposure, Unintended (3164)

Event Date 06/21/2019

Event Type  Injury  

Event Description

I was subjected to radiation coming from this meter back through my lines the other day (b)(6) 2019 with documentation of the injuries that it caused me, and i am still suffering from increased heart rate and skin still burns especially on my face.I have a landis gyr ami meter on the site of my house.I have it alloy mesh implants, mr unsafe, made by kls martin in (b)(4) (in which i filed a complaint on back in (b)(6) 2016) on the inside of my head holding up the left side of my brain with a bur hole cover on the outside with a total of 6 screws, rather a large implant.This meter is the only new factor.Within the year i lived in a home with an analog meter, healing as normal according to my drs at (b)(6) hosp then once moving into the house with a landis gyr ami meter in (b)(6) of 2016.I have had severe problems that has led me to (b)(6) to specialty drs in the field of electromagnetic fields and implant reaction.I have been diagnosed with electromagnetic hypersensitivity through a double blind test in (b)(6) at the (b)(6), founded by dr (b)(6) a leading scientist / dr in the field of electromagnetic biological effects on humans with implants.I am reporting on the implant by kls martin which was supposed to be mr safe when placed inside of my skull and with the lands gyr ami meter in which interacts with the implant.Fda safety report id# (b)(4).

• Brand Name: PLT BNE MAXILLO 2H MIC STR LN
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): KLS MARTIN MANUFACTURING, LLC
• MDR Report Key: 8744248
• MDR Text Key: 149799321
• Report Number: MW5087686
• Device Sequence Number: 1
• Product Code: HRS
• 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: 06/25/2019
• 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?: Yes
• Device Operator: No Information
• Device Model Number: 25-302-13-09
• Device Catalogue Number: 82719
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability
• Patient Age: 51 YR
• Patient Weight: 57