MAUDE Adverse Event Report: UNKNOWN DRIVE; SLING

Model Number	13220L
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/22/2019
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: SLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9192395
• Report Number: 2438477-2019-00070
• Device Sequence Number: 3730865
• Product Code: FSA
• UDI-Device Identifier: 00822383303543
• UDI-Public: 822383303543
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/15/2019
• Report Date (Section F): 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 13220L
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/14/2019
• Event Location: Nursing Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 82 YR
• Patient Weight: 55
• Date Report Sent to FDA: 10/15/2019