MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; WELLY KIDS VARIETY DECO #1

Catalog Number	WLY1015
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was originally reported to the manufacturer that the end-user experienced a skin reaction, described as a "rash," and was later diagnosed with impetigo.According to the original report, the end-user was prescribed unidentified antibiotics, unidentified steroids, and unidentified topical steroids as treatment.After multiple good faith attempts, the end-user was unable or unwilling provide additional information to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported need for medical intervention, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the end-user experienced a skin reaction and required medical treatment.

• Common Device Name: WELLY KIDS VARIETY DECO #1
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 9267845
• Report Number: 1417592-2019-00179
• Device Sequence Number: 19314566
• Product Code: KGX
• UDI-Device Identifier: 00810010440143
• UDI-Public: 00810010440143
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/01/2019

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: Lay User/Patient
• Device Catalogue Number: WLY1015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/01/2019
• 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: Required Intervention