MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BRIEF,OVERNIGHT,MD,32"-44",81CM-112CM

Catalog Number COMFORTPMMD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the end-user experienced skin breakdown and required an unidentified procedure.After multiple good-faith attempts, the facility contact was unable or unwilling to provide additional patient, product, or procedural information related to the reported incident.The reason for use and the frequency of change of the product is unknown.The location of the reported skin breakdown or the length of time between its discovery and the unidentified procedure is unknown.No additional intervention or follow-up care was reported to the manufacture.No sample was returned to the manufacturer for evaluation.A root cause could not be determined.Due to the reported incident, the need for the unidentified procedure, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the end-user experienced skin breakdown and required an unidentified procedure.

• Type of Device: BRIEF,OVERNIGHT,MD,32"-44",81CM-112CM
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 8063839
• MDR Text Key: 126913734
• Report Number: 1417592-2018-00123
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: COMFORTPMMD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR