MAUDE Adverse Event Report: JOHARI DIGITAL HEALTHCARE LIMITED NEUBIE 1.0; ELECTRIC MUSCLE STIMULATOR

Model Number 1.0

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Muscle Weakness (1967)

Event Date 04/12/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 - (b)(6) called for advice on how to treat a male minor.The minor had one session with the device approximately on (b)(6).After not feeling well for several days, he was taken to the doctor.His ck levels were extremely high so he was hospitalized from (b)(6).On (b)(6) 2022 - (b)(6) dr.Of physical therapy, had a video conference to discuss further.Through a series of questions, she was able to determine that (b)(6) did not follow standard protocol treatment even though he passed the training course.She also learned that the minor was also taking creatine supplements.

• Brand Name: NEUBIE 1.0
• Type of Device: ELECTRIC MUSCLE STIMULATOR
• Manufacturer (Section D): JOHARI DIGITAL HEALTHCARE LIMITED; g-582-584, epip, boranada; jodhpur (raj), 34201 2; IN 342012
• MDR Report Key: 14226000
• MDR Text Key: 290260135
• Report Number: 3014560945-2022-00001
• Device Sequence Number: 1
• Product Code: NGX
• UDI-Device Identifier: 08090800805253
• UDI-Public: (01)08090800805253(21)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 04/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 50 KG