MAUDE Adverse Event Report: 3M HEALTH CARE 3M CAVILON ADVANCED SKIN PROTECTANT; BANDAGE, LIQUID

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned for analysis.A trend analysis was completed with no issues identified.Based on provided information, it is unclear if 3m cavilon advanced skin protectant components, prior medical history, or use of other skin wipes or skin antiseptic cleanser could have caused or contributed to the event.
Event or Problem Description
Hives with itchiness were reported that appeared application of 3m cavilon advanced skin protectant to the gluteal cleft at the site where a prior surgery had been performed for a pilonidal cyst.An antiseptic skin cleanser was used while showering and cavilon advanced skin protectant was then applied.A non-3m brand barrier wipe was used one day prior.Hives appeared three days later; hydrocortisone cream was applied, and oral diphenhydramine was taken.An urgent care visit occurred three days later, where oral prednisone was prescribed for five days and the symptoms resolved.

• Brand Name: 3M CAVILON ADVANCED SKIN PROTECTANT
• Common Device Name: BANDAGE, LIQUID
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 11681973
• Report Number: 2110898-2021-00025
• Device Sequence Number: 3049580
• Product Code: KMF
• UDI-Device Identifier: 50707387773361
• UDI-Public: 50707387773361
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K153571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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: N/A
• Device Catalogue Number: 5050
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/16/2021
• 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
• Patient Age: 38 YR