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

Model Number P703

Device Problems Component Missing (2306); Device Dislodged or Dislocated (2923)

Patient Problem Laceration(s) (1946)

Event Date 02/16/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 311509122
• Report Number: 2438477-2023-00119
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00822383979434
• UDI-Public: 822383979434
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: P703
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2023
• Distributor Facility Aware Date: 02/20/2023
• Device Age: 3 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female