GRIP REST *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-01-23 for GRIP REST * manufactured by Better Hands Glove.

Event Text Entries

[298371] 1. Claims fda approval for treatment of carpal tunnel syndrome. 2. Does not hold the hand in cock-up neutral position recommended for cts night splints.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1027337
• MDR Report Key: 439826
• Date Received: 2003-01-27
• Date of Report: 2003-01-12
• Date Added to Maude: 2003-01-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GRIP REST
• Generic Name: WRIST APPLIANCE
• Product Code: KWN
• Date Received: 2003-01-23
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 428762
• Manufacturer: BETTER HANDS GLOVE
• Manufacturer Address: PO BOX 21641 CONCORD CA 94521 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-01-27