MAUDE Adverse Event Report: JIANGSU KONSUNG MEDICAL EQUIPMENT CO., LTD. ROSCOE; TRANSPORT CHAIR

Model Number KTA1916SA-BG

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

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

Event Date 01/05/2019

Event Type  Injury  

Event Description

A copy of the customer's medwatch 3500a (uf/importer report# (b)(4)) was mailed to compass health brands & received 1/31/2019.Per the medwatch, the patient fell at home & injured her right ankle bone.Per the patient's daughter, the patient's foot was caught on the wheelchair while attempting to transfer the patient from a bed to a chair.The patient was transported to the er, then transferred to a hospital's ipu.In the er, an x-ray was taken that revealed a confirmed bimalleolar fracture of her right ankle.The patient also presented with an 8cm laceration to her right lower extremity.The lacerated area was irrigated & cleansed in the er, and she was given iv antibiotics.

• Brand Name: ROSCOE
• Type of Device: TRANSPORT CHAIR
• Manufacturer (Section D): JIANGSU KONSUNG MEDICAL EQUIPMENT CO., LTD.; no. 8 west shengchang road; danyang economy development zo; danyang city, ; CH
• MDR Report Key: 8362761
• MDR Text Key: 136901741
• Report Number: 3012316249-2019-00006
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: KTA1916SA-BG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2019
• Distributor Facility Aware Date: 01/31/2019
• Event Location: Home
• Date Report to Manufacturer: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 86