MAUDE Adverse Event Report: ULTRASHEER / KNE MIS MED; STOCKING, MEDICAL SUPPORT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

The facility received ultrasheer/ kne mis med.However, the order should have been for jobst kn smal 20-30 mmhg.Investigation results: after review of the above issues, the following was determined: type of medication error: incorrect product; was the medication administered to the resident?: no; area where error occurred: data entry; medication(s) product(s) involved: ultrasheer/kne mis med vs jobst kn small 20-30mmhg, order error potential: low root cause; the name of the product was clearly written.In accordance with policy and procedure, the data entry tech should have entered the correct product on the order.In accordance with the policy and procedure, the pharmacist should have verified the correct product and deviated from the established policy and procedure by approving the order as correct.The data entry technician and pharmacist were not in present time with the script.(b)(6); access number: (b)(4).

• Brand Name: ULTRASHEER / KNE MIS MED
• Type of Device: STOCKING, MEDICAL SUPPORT
• MDR Report Key: 8228494
• MDR Text Key: 132796400
• Report Number: MW5082943
• Device Sequence Number: 2
• Product Code: FQL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1