MAUDE Adverse Event Report: DJO GLOBAL ENDOMED 433, RISK CLASS 2G; 'PHOTOPHERESIS' QUADPOLAR INTERFERENTIAL CONTINUOUS 9-100HZ SCAN

Model Number 1433.902

Device Problem Insufficient Information (3190)

Patient Problems Muscle Spasm(s) (1966); Weakness (2145); Tingling (2171); Cramp(s) (2193); Discomfort (2330)

Event Date 09/15/2015

Event Type  Injury  

Event Description

Reporter was treated at the physical therapist's office by use of interferential current at his lower back.He experienced tingling at his lower leg and calf.Muscle spasms at his lower back.This discomfort keeps him awake.He suspects nerve damage resulting to neuropathy.

Event Description

Add'l info received from mfr on 12/29/2015: we at djo, llc have received and reviewed mw5058129: our review team was able to contact the pt, and clinic with the pt permission for add'l details.Per the pt responding to our request, the unit involved with this event was not a djo, llc device.The data given for the device is as follows: mfr: henley international; brand name: endomed 433, risk class 2g; model # 1433.902; serial # (b)(4),.

Event Description

Add'l info received from reporter on 01/12/2016.Tingling sensation in calves.I could not sleep for many nights following use of device due to muscle spasms (twitching) of calves and lower back.Also happening various times during the day.I experienced weakness and lack of coordination.Sometimes feeling i was going to drop and needed support.Later i had muscle cramping problems as well.I advised (b)(6) before hand.I did not want any electro stim.He did not heed warning.Told him i had bad results in past.Ten units.Physical therapy: (b)(6) 2015, (b)(6) 2015.(b)(6).

• Brand Name: ENDOMED 433, RISK CLASS 2G
• Type of Device: 'PHOTOPHERESIS' QUADPOLAR INTERFERENTIAL CONTINUOUS 9-100HZ SCAN
• Manufacturer (Section D): DJO GLOBAL; 1430 decision st.; vista CA 92081
• MDR Report Key: 5250177
• MDR Text Key: 32181739
• Report Number: MW5058129
• Device Sequence Number: 0
• Product Code: LIH
• 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,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: 1433.902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/29/2015; 01/08/2016
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Other
• Patient Weight: 68