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

Model Number	1.0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Muscle Weakness/Atrophy (1967)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) was a client of evo performance.On (b)(6) 2021, (b)(6) had a training session.Later she was diagnosed with rhabdomyolysis.This was unknown to neufit unit she posted her negative experience on neufit's (b)(6) on (b)(6) 2022.Neufit reached out to evo performance for more information and was provided an description of her workout along with the waivers she signed.(b)(6) reached out to (b)(6) for more information and she did not reply.

• Brand Name: NEUBIE
• Common Device Name: NEUBIE 1.0
• Manufacturer (Section D): JOHARI DIGITAL HEALTHCARE LIMITED; g-582-584, epip, boranada; jodhpur(raj) 34201
• MDR Report Key: 14331964
• Report Number: 3015460945-2022-00002
• Device Sequence Number: 5312643
• Product Code: NGX
• UDI-Device Identifier: 08908008085253
• UDI-Public: (01)08908008085253(21)
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2022

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
• Operator of Device: Other
• Device Model Number: 1.0
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female