MAUDE Adverse Event Report: MEDX HEALTH CORP MEDX MBM 1100 CONSOLE SYSTEM; REHAB CONSOLE SYSTEM

Model Number MBM1100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 07/02/2019

Event Type  Injury  

Event Description

The (b)(6) year old female patient was initially seen at the chiropractic clinic by the doctor on (b)(6) 2019.On this date, the patient received her first treatment with the doctor using a medx health rehab console system consisted of a console (called mbm 1100-which controls the mct accessories) and two superluminescent led light cluster accessories (called mct 502, i.E.The device applied on the patient's body part-skin).The patient stated she felt better after the first treatment.The patient received her second led treatment over the same areas on (b)(6), the date of the alleged adverse event.Neither during or after the treatment was there any indication that there was any discomfort or a sensation of heat or any other negative consequence from the light therapy.The patient was scheduled for her third appointment.The patient did not attend her third treatment.The following day, the family called to say the treatments were not working, so the patient would not be continuing her treatments.They asked for their money back.On (b)(6) 2019, 22 days after the second led light therapy treatment, the daughter-in-law called the clinic and spoke to the office manager.The family informed the office manager that the patient had experienced an alleged burn from the led light therapy received at the clinic on (b)(6).No previous communication about the incident occurred before this call.The doctor , who was away on vacation, was notified immediately by the office manager.The doctor called the family that evening to determine how the patient was progressing.The family stated the treatment did not work, and that the patient sustained a burn from the treatment.They requested their money back.There were few details provided about the alleged burn during this call.It is not clear whether there were any other professional treatments or home remedies tried within the 22 days between the second led light therapy treatment and the (b)(6) call.On (b)(6), the family called the clinic again and spoke to the office manager.They said that the alleged burn was becoming worse.The office manager suggested that the family take the patient to their family physician, or if unavailable, to go to the emergency department.The office manager spoke with the family the following day and was told the patient was scheduled to see a specialist for a procedure.The family did not provide any further details about the type of specialist or 'procedure' that was to be performed.Although the office manager has reached out to the family, they have not been forthcoming with information or further details.The family have not shared any further details about the patient's alleged burn with either the chiropractor or the office manager.On (b)(6) 2019 after the clinic was notified of the alleged adverse event, the medx rehab console system was not used again.

Manufacturer Narrative

According to the doctor (chiropractor) his office has not received any further information about the patient's present condition or consequences of the alleged accident.They have tried to speak with the family but have not received any response to their calls.Therefore, there are no further details that can be added to the initial report.

Event Description

The 65 year old female patient was initially seen at the chiropractic clinic by the doctor on (b)(6) 2019.On this date, the patient received her first treatment with the doctor using a medx health rehab console system consisted of a console (called mbm 1100-which controls the mct accessories) and two superluminescent led light cluster accessories (called mct 502, i.E.The device applied on the patient's body part-skin).The patient stated she felt better after the first treatment.The patient received her second led treatment over the same areas on (b)(6), the date of the alleged adverse event.Neither during or after the treatment was there any indication that there was any discomfort or a sensation of heat or any other negative consequence from the light therapy.The patient was scheduled for her third appointment.The patient did not attend her third treatment.The following day, the family called to say the treatments were not working, so the patient would not be continuing her treatments.They asked for their money back.On (b)(6) 2019, 22 days after the second led light therapy treatment, the daughter-in-law called the clinic and spoke to the office manager.The family informed the office manager that the patient had experienced an alleged burn from the led light therapy received at the clinic on (b)(6).No previous communication about the incident occurred before this call.The doctor , who was away on vacation, was notified immediately by the office manager.The doctor called the family that evening to determine how the patient was progressing.The family stated the treatment did not work, and that the patient sustained a burn from the treatment.They requested their money back.There were few details provided about the alleged burn during this call.It is not clear whether there were any other professional treatments or home remedies tried within the 22 days between the second led light therapy treatment and the (b)(6) call.On (b)(6), the family called the clinic again and spoke to the office manager.They said that the alleged burn was becoming worse.The office manager suggested that the family take the patient to their family physician, or if unavailable, to go to the emergency department.The office manager spoke with the family the following day and was told the patient was scheduled to see a specialist for a procedure.The family did not provide any further details about the type of specialist or 'procedure' that was to be performed.Although the office manager has reached out to the family, they have not been forthcoming with information or further details.The family have not shared any further details about the patient's alleged burn with either the chiropractor or the office manager.On (b)(6) 2019 after the clinic was notified of the alleged adverse event, the medx rehab console system was not used again.

• Brand Name: MEDX MBM 1100 CONSOLE SYSTEM
• Type of Device: REHAB CONSOLE SYSTEM
• Manufacturer (Section D): MEDX HEALTH CORP; 1495 bonhill road unit #1; mississauga, L5T 1 M2; CA L5T 1M2
• MDR Report Key: 9084237
• MDR Text Key: 160176150
• Report Number: 3003725190-2019-00001
• Device Sequence Number: 1
• Product Code: ILY
• Combination Product (y/n): N
• PMA/PMN Number: K032331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MBM1100
• Device Catalogue Number: 900-0108-1101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR