MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. FLOWTRON EXCEL / TRIO PUMPS; SLEEVE, LIMB, COMPRESSIBLE

Model Number 247026

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

Patient Problem Nerve Damage (1979)

Event Date 10/12/2020

Event Type  Injury  

Event Description

It was reported to arjo that after using flowtron excel for one day after an imperial incision surgery for a patient, they found the patient is having peroneal nerve palsy.According to the hospital people including doctor, there was no malfunction on the device.During using the device, the care giver checked patient¿s legs only once or twice.

• Brand Name: FLOWTRON EXCEL / TRIO PUMPS
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• MDR Report Key: 11169062
• MDR Text Key: 226777104
• Report Number: 1419652-2021-00002
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 247026
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2021
• Distributor Facility Aware Date: 12/15/2020
• Date Report to Manufacturer: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention