MAUDE Adverse Event Report:; WHEELCHAIR

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 09/03/2017

Event Type  Injury  

Event Description

On saturday, (b)(6) 2017, (b)(6) triage received a call from the on duty nurse at (b)(6) that the patient, (b)(6) had fallen in an attempt to get out of her wheelchair without assistance and landed on her face.The patient was taken to the local emergency department.An x-ray of the patient's spine and a cat scan of the patient's head were done.The patient was diagnosed with a confirmed fracture of her c2 spine.She also had an open laceration to her left orbit requiring 4 stitches.The patient was returned to her home facility with a c-collar to her neck and a dry dressing to her left orbit area.Patient to follow up with her primary care physician and neurologist in the next week.Patient returned to prior level of care post incident with instructions to remain in bed and only get up with assistance from facility staff until follow up appointments.

• Brand Name: UNK
• Type of Device: WHEELCHAIR
• MDR Report Key: 6984473
• MDR Text Key: 90633020
• Report Number: 6984473
• 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: Other
• Type of Report: Initial
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• 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: 10/11/2017
• Distributor Facility Aware Date: 09/03/2017
• 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): Other
• Patient Age: 74 YR
• Patient Weight: 70