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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES LP; CAD ALLIANCE VIN PF LG Back to Search Results
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.
 
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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 Key18318759
MDR Text Key330385697
Report Number1417592-2023-00496
Device Sequence Number1
Product Code LYZ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
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 Number211-3207
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/16/2023
Initial Date FDA Received12/13/2023
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 Number1
Patient Outcome(s) Other;
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