MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; WIPE,PROTECTANT,SKIN,SUREPREP

Model Number	MSC1500
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Rash (2033)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer on (b)(6) 2022 they were using the sureprep wipe on their mid-abdomen when they experienced a rash.Per the customer this was the first time using the product and they had previously used adhesive remover prior to using the wipe.Per the customer the rash was described as "small red bumps".The customer stated they went to the doctor and was prescribed "desoximetasone cream usp 0.25% for the itching".Per the customer they are doing better.The sample is available but has not been returned for evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer on (b)(6) 2022 they were using the sureprep wipe on their mid-abdomen when they experienced a rash.

• Brand Name: Medline
• Common Device Name: WIPE,PROTECTANT,SKIN,SUREPREP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16110299
• Report Number: 1417592-2023-00017
• Device Sequence Number: 17559752
• Product Code: KMF
• UDI-Device Identifier: 10080196669035
• UDI-Public: 10080196669035
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: MSC1500
• Device Catalogue Number: MSC1500Z
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown