MAUDE Adverse Event Report: MEDICAL DEPOT, INC. DRIVEMEDICAL; ELECTRODE, CUTANEOUS

Model Number AGF-3X

Device Problems Loose or Intermittent Connection (1371); Peeled/Delaminated (1454); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Burn(s) (1757)

Event Date 01/21/2020

Event Type  malfunction  

Event Description

Patient states she was prescribed a tens unit for her broken back that caused severe sciatic nerve damage.She reports she was laying down with the machine patches on her outer right thigh when a live wire came out of a patch.Where the live wire touched her outer right buttock, it left a burn.She reports the battery part does not work properly.The vibration and pulse works some of the time as dialed then goes very low or does not work at all.Our medical supply office believes the patient was not using this appropriately as the lead wires were loose to the electrodes.We believe she pulled the electrodes off with the lead wires causing the wire to be exposed instead of peeling them off.Our employee showed the patient that the lead wires and the electrodes needed to be intake before using (it appeared they were pulled on and loose which could have caused the wire to be exposed).She also reviewed the instruction booklet with the patient and asked her to f/u with her physician.

• Brand Name: DRIVEMEDICAL
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): MEDICAL DEPOT, INC.; 99 seaview blvd; port washington NY 11050
• MDR Report Key: 9753572
• MDR Text Key: 180885255
• Report Number: 9753572
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AGF-3X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2020
• Event Location: Home
• Date Report to Manufacturer: 02/26/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22995 DA