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

Model Number	15030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Limb Fracture (4518)
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: BED, SEMI ELECTRIC
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12510847
• Report Number: 2438477-2021-00049
• Device Sequence Number: 11612489
• Product Code: FNL
• UDI-Device Identifier: 00822383111094
• UDI-Public: 822383111094
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/21/2021
• Report Date (Section F): 09/21/2021

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: 15030
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/26/2021
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2021
• 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: Required Intervention
• Date Report Sent to FDA: 09/21/2021