MAUDE Adverse Event Report: NEA INTERNATIONAL BV METAGRIP; ORTHOSIS, LIMB BRACE

Model Number 3.10.2

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

Patient Problem Muscle Weakness (1967)

Event Date 01/01/2021

Event Type  Injury  

Event Description

I was prescribed the metagrip by bracelab by a doctor and fitted/instructed by a therapist.After consistent use of the product my hands became weak and resulted in significant impairment in daily living.Fda safety report id# (b)(4).

• Brand Name: METAGRIP
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): NEA INTERNATIONAL BV
• MDR Report Key: 13652215
• MDR Text Key: 286513402
• Report Number: MW5107808
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/25/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 3.10.2
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White