DRIVE UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-28 for DRIVE UNKNOWN manufactured by Unknown.

Event Text Entries

[81305093] (b)(4) is the initial importer of the device which is a bariatric cane. End-user acknowledges that there is no failure of the device. Despite stating there was nothing wrong with the cane, end-user alleges that continuous use has caused nerve damage in both her hands since it does not have a gel grip. When she initially noticed the alleged damage to her hand she transferred use to the other hand causing alleged damage to both hands. She still has not discontinued use of the cane and supplements mobility with a walker when possible. She has yet to see a specialist for diagnosis and treatment but plans to see a neurologist and hand specialist. We are awaiting return of the cane and any information regarding the of the model number. She has described the cane as all metal heavy duty with round handle and no gel grip. She has also indicated that the cane weighs five (5) pounds but none of our canes weigh that much. She alleges that a physician prescribed and ordered the use of the cane. Due to lack of information we are unable to identify the manufacturer of the device.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2438477-2017-00062
• MDR Report Key: 6750750
• Date Received: 2017-07-28
• Date of Report: 2017-06-30
• Date Facility Aware: 2017-06-27
• Report Date: 2017-07-28
• Date Reported to FDA: 2017-07-28
• Date Added to Maude: 2017-07-28
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DRIVE
• Generic Name: BARIATRIC CANE
• Product Code: IPS
• Date Received: 2017-07-28
• Model Number: UNKNOWN
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNKNOWN
• Manufacturer Address: US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-07-28