MAUDE Adverse Event Report: JIAXING CONSMA HEALTHCARE PRODUCTS CO LTD ECONOMY RED ROLLATOR WITH CURVED BACKREST; WALKER, MECHANICAL

Model Number 65650R

Device Problem Insufficient Information (3190)

Patient Problem Brain Injury (2219)

Event Date 11/02/2017

Event Type  Injury  

Manufacturer Narrative

The patient's wife did not elaborate on why she believed the rollator was related to the fall and subsequent injury.While the rollator may have been in use when the patient fell, it is not clear that a malfunction occurred.The patient's wife was not willing to provide further information regarding the event, and she refused to return the rollator to invacare for evaluation.She reported that the patient has inclusion body myositis, which is a muscle disease that causes weakness of the limb muscles.Additionally, the patient has heart disease and renal failure, and he is under hospice care.It is likely that the patient's medical conditions contributed to his alleged fall.The manufacturer of this device is no longer in business.

Event Description

The patient's wife reported that her husband fell, which resulted in a head injury.She stated that her husband had a cat scan which revealed a brain bleed, and he received staples.He was then sent to a second hospital with a neurologist, where they performed two additional cat scans.The patient's wife alleged that the fall was related to the rollator.

• Brand Name: ECONOMY RED ROLLATOR WITH CURVED BACKREST
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): JIAXING CONSMA HEALTHCARE PRODUCTS CO LTD; no. 158 huicheng road; huimin ind.; jianshan, zhejiang ; CH
• MDR Report Key: 7086289
• MDR Text Key: 93827977
• Report Number: 1531186-2017-00016
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/06/2017,11/07/2017

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
• Device Operator: Lay User/Patient
• Device Model Number: 65650R
• Device Lot Number: CK120720
• 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: 12/06/2017
• Distributor Facility Aware Date: 11/07/2017
• Device Age: 5 YR
• Event Location: Home
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening