MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CAD ALLIANCE VIN PF LG

Catalog Number 211-3207

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 10/13/2023

Event Type  Injury  

Manufacturer Narrative

It was reported by the customer contact that on 10/13/2023, a user "developed rash and ongoing skin issues using this product".It was reported that due to this, medical attention was required and a corticosteroid cream was required and the user "remains on modified duty to date".A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

A user developed a rash.

• Type of Device: CAD ALLIANCE VIN PF LG
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18318759
• MDR Text Key: 330385697
• Report Number: 1417592-2023-00496
• Device Sequence Number: 1
• Product Code: LYZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2023

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
• Device Catalogue Number: 211-3207
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/13/2023
• 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