MAUDE Adverse Event Report: COMPASS RICHMAR RICHMAR; THERATOUCH 7.7S

Model Number 400-080

Device Problems Use of Device Problem (1670); Connection Problem (2900)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Type  Injury  

Manufacturer Narrative

Based on evaluation testing of the device, there is no problem with the device as it meets all functional test specifications.The electrode; lead wires; accessories in use with the device did show heavy wear and unexpected changes in "resitance" when measured.The resitance change in the wire would lead to a change in output of the stimulator.The resitance change in the lead wire is the most plausible explanation for the reported event, as a change in resitance could lead to an unexpected change in output to the patient, which could "casue" higher than intended energy levels resulting in burns.The "manufcature" publishes lead cord "maintenacne" with the device and provides labelling with the lead cords for the user to add date lead cords were put into service and a "replace by" date one year from the in service date.Furthermore, the manufacture recommends lead cords be tested monthly for maintenance.(b)(4).

Event Description

Distributor reported the following statement to compass richmar technical service on 11/14/2018: "patient reported increased intensity during treatment.Treatment was stopped and would not reset.Redness noted next visit.Wound progressed to present with black scar.'pateint' refered to pcp when no significant healing occurred.Pt told: full-thickness (3rd degree) electrical burns." location of the injury is on the knee.

• Brand Name: RICHMAR
• Type of Device: THERATOUCH 7.7S
• Manufacturer (Section D): COMPASS RICHMAR; 4120 south creek rd; chattanooga TN 37406
• Manufacturer (Section G): COMPASS RICHMAR; 4120 south creek rd; chattanooga 37406
• Manufacturer Contact: anthony shaw ; 4120 south creek rd; chattanooga 37406 ; 4236487730
• MDR Report Key: 8152426
• MDR Text Key: 129967275
• Report Number: 3004750362-2018-00001
• Device Sequence Number: 1
• Product Code: IPF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 400-080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ELECTRODE (TENS)ELECTRODE LEAD WIRES; ELECTRODE LEAD WIRES
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 113