MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL EQUIPMENT ROLLATOR 9153651315; WALKER, MECHANICAL

Model Number 65650

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problems Discomfort (2330); Injury (2348)

Event Type  Injury  

Event Description

The caller states the consumer sat on the seat and the front wheel collapsed and dumped the consumer on the floor.The caller states the consumer weighs about (b)(6) pounds.The caller states the consumer was sore after the fall and they did mri to check for injuries and was confirmed no injury internal.The caller did state the consumer is still sore.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: rollators.Other, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the rollator collapsing.The front right caster was observed to be unable to attach properly due to damaged threading.Complaint was confirmed.The underlying cause is damaged threading.Root cause could not be determined after reviewing the documentation in this investigation.

Event Description

Product was returned for evaluation.The return fields in oracle state: rollators.Other, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the rollator collapsing.The front right caster was observed to be unable to attach properly due to damaged threading.The caller states the consumer sat on the seat and the front wheel collapsed and dumped the consumer on the floor.The caller states the consumer weighs about (b)(6).The caller states the consumer was sore after the fall and they did mri to check for injuries and was confirmed no injury internal.The caller did state the consumer is still sore.

• Brand Name: ROLLATOR 9153651315
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DANYANG MAXTHAI MEDICAL EQUIPMENT; danyang ; CH
• MDR Report Key: 5563936
• MDR Text Key: 42346825
• Report Number: 1531186-2016-00010
• 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: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/07/2016,04/19/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 65650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2016
• Distributor Facility Aware Date: 04/19/2016
• Device Age: 27 MO
• Date Report to Manufacturer: 04/07/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 109