CURAD SIZE D COMPRESSION STOCKINGS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-07 for CURAD SIZE D COMPRESSION STOCKINGS manufactured by Unk.

Event Text Entries

[132792394] The facility received an order for curad 20-30mmhg size d compression stockings. However, the order should have been for a size a compression stocking. Investigation results: after a review of the above issues, the following was determined. Type of medication error: incorrect product; was the medication administered to the resident? Na. Area where error occurred: data entry and initial review medication (s) / product(s) involved: curad size d compression stocking vs curad size a compression stockings, order error potential: low root cause: the measurements on the prescription was clearly written. In accordance with policy and procedure, the data entry technician should have entered the correct size according to the measurements on the order. In accordance with policy and procedure, the pharmacist should have verified the correct size according to the measurements and deviated from established policy and procedure by approving the order as correct. The data entry technician and pharmacist were not in present time with the prescription. (b)(6); access number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5082944
• MDR Report Key: 8228498
• Date Received: 2019-01-07
• Date of Report: 2018-05-23
• Date Added to Maude: 2019-01-08
• 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
• 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: CURAD SIZE D COMPRESSION STOCKINGS
• Generic Name: STOCKING, MEDICAL SUPPORT
• Product Code: FQL
• Date Received: 2019-01-07
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-01-07