MAUDE Adverse Event Report: RESIN/ROOT CANAL FILLING

Device Problem Vibration (1674)

Patient Problems Hair Loss (1877); Pain (1994); Burning Sensation (2146); Complaint, Ill-Defined (2331); Numbness (2415)

Event Date 01/01/2011

Event Type  Injury  

Event Description

Notice changes with body gradually.Hair loss, sharp pains, overheating areas, repeated vibration, numbness, etc., to targeted areas of body (whole).Over the course of years following, the issues are now sudden, (there's pattern to when symptom appear/go away).The pain is at times intense, other times mild/moderate.It occurs now everyday.

Event Description

Add'l info received from reporter for report mw5056112.Initial incident occurred in year of 2011; have sent reports over the course of past years after; are sending report due to health issues worsening with visible damage to specific areas complained several times to varied drs / specialists and now other areas of the body that are intact are now adversely targeted with increased pain, injured without any symptoms and no other type of associated sickness / illness, this problem have encountered a chronic and sudden effect upon my health.This issue mainly surrounds heavy static charge that is excessive, continuous heavy info around skin and clothing and aids in direct nausea on contact.In the meantime i'm still seeing drs for these same chronic issues.Class ii fda device implanted.Fda safety report id# (b)(4).

• Brand Name: RESIN/ROOT CANAL FILLING
• Type of Device: RESIN/ROOT CANAL FILLING
• MDR Report Key: 5075020
• MDR Text Key: 25786021
• Report Number: MW5056112
• Device Sequence Number: 1
• Product Code: KIF
• 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,Followup
• Report Date: 09/08/2015

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 34 YR
• Patient Weight: 80