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

Model Number	15001ABV
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a bed rail by an end user's aide, who stated that she "found [the end user] with his neck and arm stuck in the bed rail," and that "the spring-loaded knob has failed and they are no longer able to adjust the rails." the aide did not specify the location where the end user's neck and arm were stuck.The aide reported that the end user sustained some bruising to his knees, but did not specify how the bruising was related to the incident.The aide specified that the end user did not require any medical treatment.Drive made several attempts to contact the reporter and end user in order to retrieve the product for inspection but was unable to make further contact.Drive will continue to monitor for any related trends.
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a bed rail by an end user's aide, who stated that she "found [the end user] with his neck and arm stuck in the bed rail," and that "the spring-loaded knob has failed and they are no longer able to adjust the rails." the aide did not specify the location where the end user's neck and arm were stuck.The aide reported that the end user sustained some bruising to his knees, but did not specify how the bruising was related to the incident.The aide specified that the end user did not require any medical treatment.Drive made several attempts to contact the reporter and end user in order to retrieve the product for inspection but was unable to make further contact.Drive will continue to monitor for any related trends.

• Brand Name: DRIVE
• Common Device Name: BED RAILS
• Manufacturer (Section D): SHENYANG HENYI ENTERPRISE CO., LTD; no.386-3 qingnian st.; heping dis.; shenyang, liaoning 11000 4; CH 110004
• MDR Report Key: 17371068
• Report Number: 2438477-2023-00080
• Device Sequence Number: 19799141
• Product Code: FNL
• UDI-Device Identifier: 00822383179490
• UDI-Public: 822383179490
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023
• Report Date (Section F): 07/21/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 15001ABV
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/23/2023
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 07/21/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/02/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 95 KG
• Date Report Sent to FDA: 07/21/2023