MAUDE Adverse Event Report: UNKNOWN DRIVE; SLING

Model Number 13220L

Device Problem Material Fragmentation (1261)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/22/2019

Event Type  Injury  

Event Description

Drive devilbiss is the initial importer of the device which is a sling used in conjunction with a patient lift.This report is in response to a medwatch form forwarded by the nursing center that was forwarded to drive, we have not evaluated the sling to date.While transferring a patient using a mechanical lift, the strap on the lift sling broke resulting in the resident falling to the floor.Patient reportedly suffered fractures.

• Brand Name: DRIVE
• Type of Device: SLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9192395
• MDR Text Key: 162338782
• Report Number: 2438477-2019-00070
• Device Sequence Number: 1
• Product Code: FSA
• UDI-Device Identifier: 00822383303543
• UDI-Public: 822383303543
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13220L
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2019
• Distributor Facility Aware Date: 10/14/2019
• Event Location: Nursing Home
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR
• Patient Weight: 55