MAUDE Adverse Event Report: COVIDIEN T.E.D. STOCKINGS; STOCKING, MEDICAL SUPPORT

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Sizing chart incorrect on packaging/ potential chance mis - sizing with possible strangulation of limbs.Same product has two different sizing charts.

• Brand Name: T.E.D. STOCKINGS
• Type of Device: STOCKING, MEDICAL SUPPORT
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 6861542
• MDR Text Key: 86151396
• Report Number: MW5072123
• Device Sequence Number: 1
• Product Code: DWL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention