MAUDE Adverse Event Report: UNKNOWN DRIVE; APP

Model Number	14530
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	05/19/2019
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: APP
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8942564
• Report Number: 2438477-2019-00059
• Device Sequence Number: 16758973
• Product Code: FNM
• UDI-Device Identifier: 00822383179490
• UDI-Public: 822383179490
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/28/2019
• Report Date (Section F): 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 14530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/13/2019
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 08/28/2019