MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. ROSCOE MEDICAL; THERATOUCH CX4 W/THERAPY CART

Model Number DQ8001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 03/08/2023

Event Type  Injury  

Event Description

Severely burned patient unit needs to be checked out by vendor.Pre-existing medical conditions is paraplegia, mild edema.Device is 4 years old and used for 4 years.No other devices were being used at the time of event.No discomfort at time or after incident.Used in ifc 40 ma.Unit last serviced 5/18/2022 prior to incident.They are using 2" by 4" self adhesive electrodes on b anterior tibialis, 2 each le, 4" apart.New electrodes , only one use.Nothing was applied to the skin prior and device was turned off when pads were removed/adjusted.Skin was clear.Burns appeared the next day, (b)(6) 2023, and resolved on (b)(6) 2023.They do not have experience with this waveform.The patient did seek medical attention and they have the medical records.Electrodes are not shared between multiple patients and are stored in original package in therapy gym.They were using ifc, 4 electrodes, 2 per le.Patient has no known allergies.They are using 2" x 4" dura-stick plus electrodes.They have not tried new leads, unit is out of service after incident.Leads show no damage.User manual attached.Page 6, warning: do not use this device under these conditions, 5th bulletin: "· over areas of skin that lack normal sensation." warning (cont.), general warnings:, page 8, 6th bulletin: "before administering any treatment to a patient you should become acquainted with the operating procedures for each mode of treatment available, as well as the indications, contraindications, warnings and precautions.Consult other resources for additional information regarding the application of electrotherapy and ultrasound." page 8, electrotherapy warnings, 2nd bulletin: "this device is to be used as a symptomatic treatment for pain and has no curative value.Patients should be cautioned and their activities regulated if pain that would otherwise serve as a protective mechanism is suppressed.".On 01-31-2024 customer reported "severely burned patient unit needs to be checked out by vendor" with no response until 03/08/2024 where they provided the additional information.

• Brand Name: ROSCOE MEDICAL
• Type of Device: THERATOUCH CX4 W/THERAPY CART
• Manufacturer (Section D): SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.; floor 1-2, no.3 building, fans; industrial estate xilixiaobaim; shenzhen guangdong, 51810 8; CH 518108
• MDR Report Key: 19005934
• MDR Text Key: 338981898
• Report Number: 3012316249-2024-00006
• Device Sequence Number: 1
• Product Code: GYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DQ8001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2024
• Distributor Facility Aware Date: 03/08/2024
• Device Age: 56 MO
• Event Location: Other
• Date Report to Manufacturer: 03/29/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 78 KG