MAUDE Adverse Event Report: COVIDIEN, FORMERLY KENDALL, A DIVISION OF TYCO HEALTHCARE T.E.D. ANTIEMBOLISM STOCKINGS KNEE LENGTH; STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Scarring (2061); Injury (2348)

Event Date 03/03/2014

Event Type  No Answer Provided  

Event Description

The patient delivered a full term infant and per usual plan of care had t.E.D.Knee length stockings placed.Postpartum, she complained of pain in her left foot and ankle.When the nurse pulled the foot part of the t.E.D.Stockings up, there was a blister on the front of the left ankle.Since discharge, the patient has developed a scar across the front of her ankle.She states that she continues to have pain from the scar and will be consulting with a plastic surgeon in the future.

• Brand Name: T.E.D. ANTIEMBOLISM STOCKINGS KNEE LENGTH
• Type of Device: STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LE
• Manufacturer (Section D): COVIDIEN, FORMERLY KENDALL, A DIVISION OF TYCO HEALTHCARE; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 4557813
• MDR Text Key: 5459144
• Report Number: 4557813
• Device Sequence Number: 1
• Product Code: DWL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2015
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 50