MAUDE Adverse Event Report: UNKNOWN DRIVE; BED, SEMI ELECTRIC

Model Number 15030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Limb Fracture (4518)

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a bed.The device has not been returned for evaluation.We will file a follow up if additional data becomes available.The device was installed without the headboard and footboard.The mattress slipped off the bed.The end user threw herself to the floor because she was miserable.She was taken to the hospital where she stayed overnight.She broke her arm in the fall.The device did not precipitate the incident.

• Brand Name: DRIVE
• Type of Device: BED, SEMI ELECTRIC
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12510847
• MDR Text Key: 272722064
• Report Number: 2438477-2021-00049
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00822383111094
• UDI-Public: 822383111094
• 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
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 15030
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2021
• Distributor Facility Aware Date: 08/26/2021
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention