MAUDE Adverse Event Report: GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD MERIDIAN OPTIMUM COMFORT GEL CUSHION

Model Number HDC-9B 18X16

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

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 10/20/2018

Event Type  Injury  

Event Description

Patient was sitting at the table in a regular chair with her gel cushion and slid off the gel cushion to the floor.Patient sustained right hip fracture and required surgical repair.X-ray done at emergency room confirmed fracture of the right hip.

• Brand Name: MERIDIAN OPTIMUM COMFORT GEL CUSHION
• Type of Device: GEL CUSHION
• Manufacturer (Section D): GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD; 1805 honggao road; xiuzhou industry zone; jiaxing zhejiang, ; CH
• MDR Report Key: 8031053
• MDR Text Key: 125904829
• Report Number: 3012316249-2018-00055
• Device Sequence Number: 1
• Product Code: IMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HDC-9B 18X16
• 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: 11/01/2018
• Distributor Facility Aware Date: 10/26/2018
• Event Location: Home
• Date Report to Manufacturer: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 48