MAUDE Adverse Event Report: UNKNOWN DRIVE; APP

Model Number 14530

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

Patient Problem Bruise/Contusion (1754)

Event Date 05/19/2019

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the devices: a bed rail and a low "ait" loss system.Patient was in hospice care when the incident occured.The patient 's daughter reported to service technician during equipment pick that patient got foot stuck between the bed and head board causing her to lose blood flow.She stated she had a choice to amputate foot or suffer from gangrene until she died.Hospice reported to the provider that patient had foot injury.They visited that day to evaluate patient foot.No other information is available.

• Brand Name: DRIVE
• Type of Device: APP
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8942564
• MDR Text Key: 158660426
• Report Number: 2438477-2019-00059
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 00822383179490
• UDI-Public: 822383179490
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2019
• Distributor Facility Aware Date: 07/13/2019
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention