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

Model Number	15001ABV
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) healthcare is the initial importer of the device which is a bed rail.We have not evaluated the device as the service provider is holding it at their facility.We will file a follow-up report once we are able to evaluate the device and/or receive additional information.End-user reported he had to go to the hospital due to a cut and infection in his right leg.He was not sure how he got the cut on his leg.After being discharged from the hospital he found a "sharp spot" on the side rails that cut his hand.

• Brand Name: DRIVE
• Common Device Name: BED
• Manufacturer (Section D): SHENYANG HENYI ENTERPRISE CO., LTD; no.386-3 qingnian st.; heping dis., shenyang 11000 4; CH 110004
• MDR Report Key: 11323258
• Report Number: 2438477-2021-00002
• Device Sequence Number: 16978004
• Product Code: FNL
• UDI-Device Identifier: 00822383179490
• UDI-Public: 822383179490
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2021
• Report Date (Section F): 02/12/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 15001ABV
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/28/2021
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 02/17/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Date Report Sent to FDA: 02/12/2021