MAUDE Adverse Event Report: UNKNOWN; BRODA CHAIR

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

Patient Problems Fall (1848); Bone Fracture(s) (1870); Head Injury (1879)

Event Date 12/10/2018

Event Type  Injury  

Event Description

Pt was in activity area at nursing facility with other residents and 2 staff personal.Pt slid from broda chair while staff were assisting other residents.Pt was found lying on left side with bleeding noted from head.Pt was given first aide by facility staff.Transported to (b)(6) hosp emergency room.Hme was notified of incident, at this time mfr of chair is unk.

• Brand Name: UNKNOWN
• Type of Device: BRODA CHAIR
• MDR Report Key: 8208264
• MDR Text Key: 131907321
• Report Number: 8208264
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2018
• Distributor Facility Aware Date: 12/10/2018
• Event Location: Nursing Home
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 85 YR
• Patient Weight: 58