MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; DRESSING,PLUROGEL, 50G,1.75OZ TUBE

Catalog Number	PGL050TUBE
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146)
Date of Event	05/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient experienced a burning sensation when her physician applied plurogel to her legs.It was not identified why the patient required plurogel application.The patient then experienced pain to her legs and on (b)(6) 2019 she reportedly saw her physician.The physician injected an unidentified medication into the patient's left leg and was stopped before injecting her right leg.The reason for the injection was unknown to the patient.Reportedly, the patient is now also "getting a nurse at home." no diagnostic exams/results, diagnoses, or additional treatments were reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the reported incident, the reported medical treatment, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch.
Event or Problem Description
It was reported that the patient experienced a burning sensation upon application of the plurogel.

• Common Device Name: DRESSING,PLUROGEL, 50G,1.75OZ TUBE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8780661
• Report Number: 1417592-2019-00113
• Device Sequence Number: 19492796
• Product Code: NAE
• UDI-Device Identifier: 10888277693494
• UDI-Public: 10888277693494
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PGL050TUBE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 64