MARATHON

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-27 for MARATHON manufactured by Medline.

Event Text Entries

[74167738] Product is marathon "liquid skin protectant" manufactured for medline industries, (b)(4). Product information data sheet claims that it is a "non-cytotoxic fast-drying liquid barrier film for the protection of damaged or intact skin". It claims it is "no sting" and is intended "to protect or damaged skin from the effects of moisture, friction (rubbing), or shear (tearing). " this data is incorrect and/or misleading, because my patient experiences excruciating pain when it is applied to the damaged skin of his buttocks. He is paraplegic and lies on his buttocks most of the time. Dose or amount: 0. 5 g grams. Frequency: 4 times a day. Route: topical. Therapy start date: (b)(6) 2017. Therapy end date: (b)(6) 2017. Diagnosis or reason for use: decubitus ulcer buttocks. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5069441
• MDR Report Key: 6533440
• Date Received: 2017-04-27
• Date of Report: 2017-04-27
• Date of Event: 2017-04-25
• Date Added to Maude: 2017-05-01
• 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: MARATHON
• Generic Name: MARATHON
• Product Code: KMF
• Date Received: 2017-04-27
• Lot Number: P00205825
• Device Expiration Date: 2018-06-28
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDLINE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-04-27