MAUDE Adverse Event Report: UNKNOWN DRIVE; SLING FOR PATIENT LIFT

Model Number 13221L

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Bruise/Contusion (1754); Fall (1848); Laceration(s) (1946)

Event Date 03/15/2018

Event Type  Injury  

Event Description

Drive devilbiss is the initial importer of the device which is a sling.The resident was being lifted from the bed to her chair.The lift was inspected prior to placing under the resident but the 2 cna's using it and it appeared to be sturdy.They were midway through taking her from her bed to her specialty chair and the strap broke off.The resident fell to the ground approx.4 feet and landed on the legs of the lift.The patient suffered a laceration to right arm which required sutures and bruising to her right shin/calf which required debridement.

• Brand Name: DRIVE
• Type of Device: SLING FOR PATIENT LIFT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 7582363
• MDR Text Key: 110515940
• Report Number: 2438477-2018-00031
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nursing Assistant
• Device Model Number: 13221L
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2018
• Event Location: Nursing Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other