TED HOSE KNEE HIGH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-20 for TED HOSE KNEE HIGH manufactured by Unk.

Event Text Entries

[131587295] The facility received an order for ted hose knee high. However, the order should have been for ted hose thigh high. 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 and initial review medication(s)/product(s) involved, ted hose knee high vs thigh high order error potential, low root cause, the correct product was clearly written. In accordance with policy and procedure, the data entry technician should have entered the correct dosage on the order. In accordance with the policy and procedure, the pharmacist should have verified the correct dosage 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5082522
• MDR Report Key: 8191681
• Date Received: 2018-12-20
• Date of Report: 2018-12-20
• Date Added to Maude: 2018-12-21
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: TED HOSE KNEE HIGH
• Generic Name: STOCKING MEDICAL SUPPORT
• Product Code: FQL
• Date Received: 2018-12-20
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-12-20