MAUDE Adverse Event Report: UNKNOWN DRIVE; BARIATRIC CANE

Model Number UNKNOWN

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

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Event Description

(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.

• Brand Name: DRIVE
• Type of Device: BARIATRIC CANE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 6750750
• MDR Text Key: 81305093
• Report Number: 2438477-2017-00062
• Device Sequence Number: 1
• Product Code: IPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/28/2017,06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2017
• Distributor Facility Aware Date: 06/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 171