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

Model Number 1.0

Device Problem Insufficient Information (3190)

Patient Problem Muscle Weakness (1967)

Event Date 04/01/2021

Event Type  Injury  

Event 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
• Type of Device: NEUBIE 1.0
• Manufacturer (Section D): JOHARI DIGITAL HEALTHCARE LIMITED; g-582-584, epip, boranada; jodhpur(raj) 34201
• MDR Report Key: 14331964
• MDR Text Key: 291240285
• Report Number: 3015460945-2022-00002
• Device Sequence Number: 1
• Product Code: NGX
• UDI-Device Identifier: 08908008085253
• UDI-Public: (01)08908008085253(21)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Device Model Number: 1.0
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2022
• 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): Other
• Patient Sex: Female