MAUDE Adverse Event Report: XIAMEN WORLD GEAR SPORTS GOODS CO., LTD DRIVE; BED

Model Number	P703
Medical Device Problem Codes	Component Missing (2306); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bed by an assisted living facility, which reported that "an end user went to swing her legs out of bed and caught her legs on the bed frame, requiring stitches and high level of care." it was reported that the bed was missing the end caps on the frame segments, revealing the metal edge.The end caps are intended to protect the end user from contact with the metal edge.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: BED
• Manufacturer (Section D): XIAMEN WORLD GEAR SPORTS GOODS CO., LTD; 27-29 north 2nd road; xiamen, fujian 36102 2; CH 361022
• MDR Report Key: 16566220
• Report Number: 2438477-2023-00119
• Device Sequence Number: 17526626
• Product Code: FNL
• UDI-Device Identifier: 00822383979434
• UDI-Public: 822383979434
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2023
• Report Date (Section F): 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: P703
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/20/2023
• Device Age: 3 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2023
• 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
• Patient Sex: Female
• Date Report Sent to FDA: 03/17/2023