MAUDE Adverse Event Report: SHENYANG HENYI ENTERPRISE CO., LTD DRIVE; PATIENT LIFT

Model Number 13023SV

Device Problem Misassembled (1398)

Patient Problem Skin Tears (2516)

Event Date 04/24/2018

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a patient lift.The device was delivered and not assembled correctly.The caregiver reported that the device was not defective, however, the delivery guy assembled the patient lift incorrectly.In his haste he did not screw the thumbscrew all the way in.The patient's leg caught was suffered a 6 inch skin tear.

• Brand Name: DRIVE
• Type of Device: PATIENT LIFT
• Manufacturer (Section D): SHENYANG HENYI ENTERPRISE CO., LTD; no.386-3 qingnian st.; heping dis.; shenyang, liaoning 11000 4; CH 110004
• MDR Report Key: 7520665
• MDR Text Key: 108487414
• Report Number: 2438477-2018-00027
• 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: Nursing Assistant
• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: 13023SV
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2018
• Distributor Facility Aware Date: 05/09/2018
• Event Location: Home
• Date Report to Manufacturer: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 86