MAUDE Adverse Event Report:; PNEUMATIC TOURNIQUET

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

Patient Problems Ecchymosis (1818); Discharge (2225)

Event Date 10/30/2020

Event Type  No Answer Provided  

Event Description

Patient was admitted for left total knee arthroplasty.Patient assumed normal post op course.Received phone call 3 days later regarding post operation drainage.Advised to do compressive dressing, rest, ice.Received patient message thru portal with image 2 days later to review incision in regards to drainage.Patient with severe ecchymosis in entire extremity.Recommend conservative treatments.Patient came for eval 5 days later in office.Patient continues with severe ecchymosis and soreness throughout entire lower left extremity.Drainage has resolved and wound appears noninfectious.30-inch tourniquet applied to left thigh by nurse.Tourniquet #: (b)(4).Pressure = 225.Inflation time 19 minutes.Patient care manager made aware of issue by surgeon's office.She emailed our biomedical engineering department regarding same.

• Type of Device: PNEUMATIC TOURNIQUET
• MDR Report Key: 11010627
• MDR Text Key: 221547397
• Report Number: 11010627
• Device Sequence Number: 1
• Product Code: KCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1