DYNATRONIC DYNATRON 800 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-08-09 for DYNATRONIC DYNATRON 800 * manufactured by Dynatronic Corp..

Event Text Entries

[160213] Pt was set-up on interferential electrical stimulator to left knee as ordered by physician. Approximately 5 mins later, while receiving the treatment, pt verbalized that he felt the stimulation intensify at the left lateral quadriceps area. Treatment immediately stopped. Area examined. Rn and md notified. Md noted superficial redness of lateral aspect of left knee area. Silvadene creme applied.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1016920
• MDR Report Key: 235621
• Date Received: 1999-08-09
• Date of Report: 1999-07-20
• Date of Event: 1999-07-08
• Date Added to Maude: 1999-08-17
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DYNATRONIC
• Generic Name: COMBINATION THERAPY UNIT
• Product Code: LIH
• Date Received: 1999-08-09
• Returned To Mfg: 1999-07-19
• Model Number: DYNATRON 800
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 228347
• Manufacturer: DYNATRONIC CORP.
• Manufacturer Address: 7030 CENTRE DRIVE SALT LAKE CITY UT 84121 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-08-09