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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENYANG HENYI ENTERPRISE CO. DRIVE; LIFT, PATIENT, AC-POWERED
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SHENYANG HENYI ENTERPRISE CO. DRIVE; LIFT, PATIENT, AC-POWERED Back to Search Results
Model Number 13023SV
Device Problem Sharp Edges (4013)
Patient Problem Laceration(s) (1946)
Event Date 08/18/2023
Event Type  Injury  
Event Description
Drive devilbiss healthcare was notified of a complaint involving a patient lift device.The reporter indicated that the user sustained a 4-5 inch cut across her leg by the release valve of the patient lift device when the user was being guided over the bed.The user received treatment by the nurse who applied binding paste to the cut.The investigation is ongoing and a follow up report will be submitted when the manufacturer has completed the investigation.
 
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Brand Name
DRIVE
Type of Device
LIFT, PATIENT, AC-POWERED
Manufacturer (Section D)
SHENYANG HENYI ENTERPRISE CO.
no.386-3 qingnian st.
heping dist.
shenyang, 11000 4
CH  110004
MDR Report Key17846022
MDR Text Key324620969
Report Number2438477-2023-00127
Device Sequence Number1
Product Code FNG
UDI-Device Identifier00822383135441
UDI-Public822383135441
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/29/2023
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? Yes
Device Operator Lay User/Patient
Device Model Number13023SV
Device Catalogue Number13023SV
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/29/2023
Distributor Facility Aware Date08/30/2023
Event Location Home
Date Report to Manufacturer09/29/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/29/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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