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

Model Number	N/A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Superficial (First Degree) Burn (2685)
Date of Event	11/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was not provided.Estimated date of event since the exact date was not reported.No lot number was provided.3m¿ cavilon¿ advanced skin protectant was used with electrocautery.The ifu contains warnings that 3m cavilon advanced skin protectant is highly flammable until it has completely dried on the skin and should only be applied when no ignition sources or heat-producing devices are in use.
Event or Problem Description
A flammability event was reported after application of 3m cavilon advanced skin protectant and use of electrocautery in the operating room during a cardiac surgery.Erythema on the chest at the incision site was observed.An in-service was conducted for operating room staff by 3m after the incident occurred.The product ifu contains warnings that 3m cavilon advanced skin protectant is highly flammable until it has completely dried on the skin and should only be applied when no ignition sources or heat-producing devices are in use.
Event or Problem Description
A flammability event was reported after application of 3m cavilon advanced skin protectant that was applied in preparation for application of a wound vac in the operating room during a cardiac surgery.A cautery device was used to cauterize a small blood vessel, which resulted in a small flash flame and first degree burn with erythema on the chest at the incision site.Minor treatment was reported and the burn healed well.An in-service was conducted for operating room staff by 3m after the incident occurred.The product ifu contains warnings that 3m cavilon advanced skin protectant is highly flammable until it has completely dried on the skin and should only be applied when no ignition sources or heat-producing devices are in use.

• 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: 10950616
• Report Number: 2110898-2020-00065
• Device Sequence Number: 19640931
• Product Code: KMF
• UDI-Device Identifier: 50707387773361
• UDI-Public: 50707387773361
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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 Model Number: N/A
• Device Catalogue Number: 5050
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELECTROCAUTERY TOOL
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR