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	Anaphylactoid / Anaphylaxis (2218)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was not provided.No sample is available for analysis.A trend analysis was completed and manufacturing records were reviewed for the reported lot number with no issues identified.There is no sufficient clinical information available for a robust medical interpretation.An allergic reaction may be possible for this case; however, if 3m cavilon advanced skin protectant was primarily involved in the reaction it cannot be clearly assessed.Also, the intensity of the reaction is not well documented.Allergy testing should be done to verify a potential allergic reaction.
Event or Problem Description
Received from (b)(6): anaphylaxis was reported for a patient who was taken to the hospital by ambulance while using 3m cavilon advanced skin protectant 5050g.Detail regard the symptoms experienced was not provided, and it is not known if there was any medical intervention.The patient fully recovered.Nothing was reported to be used in combination with cavilon advanced.The leg was cleaned with nacl and gauze.Silvercel/carboflex/flivasorb applied to the leg and secured with crepe bandage, after which cavilon advanced skin protectant was applied to the foot with a stockinette to cover.

• 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
• Manufacturer (Section G): 3M COMPANY 3M COLUMBIA; 5400 paris road; columbia MO 65202
• Manufacturer Contact: dianne gibbs ; 3m center building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 13981184
• Report Number: 2110898-2022-00030
• Device Sequence Number: 17590603
• Product Code: KMF
• UDI-Device Identifier: 50707387773361
• UDI-Public: 50707387773361
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K153571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2022

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: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: N/A
• Device Catalogue Number: 5050G
• Device Lot Number: 0007791786
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SILVERCEL/CARBOFLEX/FLIVASORB
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown