MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ CAVILON¿ NO STING BARRIER FILM; CAVILON NO STING BARRIER FILM

Model Number	N/A
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information not provided.Exact date of event is unknown.Event was reported to occur on approx.(b)(6) 2019.Lot # not provided, therefore expiration date is unknown.Lot # not provided, therefore manufacture date is unknown.This complaint is for a flammability event that occurred in (b)(6) 2019.The flammability event is not due to a product defect or problem with this specific lot.The product is flammable until it is completely dry and vapors have dissipated.A flammability event will occur if the product is exposed to an ignition source before the vapors are dissipated.There is flammability information in cavilon no sting barrier film ifus and a flame symbol on each individual pouch.For this application, cavilon no sting barrier film catalog number 3344ens is provided non-sterile to acelity as a component of their kit.I it is unclear if the cavilon¿ no sting barrier film flammability symbol could be seen in the kit.Cautery was the ignition source for this event.The root cause of the flammability event is cautery ignited cavilon no sting barrier film vapors before the vapors dissipated.End of report.
Event or Problem Description
A representative reported 3m¿ cavilon¿ no sting barrier film was alleged to have caught on fire while on a patient.A vac ultra therapy device and a veraflo¿ choice dressing was reportedly used.The representative reported a (b)(6)-year-old white female developed a quarter size reddened area (burn) to the right of her sternum.The skin was prepped with povidone iodine.The patient was reported to have an allergy history to bactrim.No other skin sensitivities were specified.The patient did not require medical intervention.There was no notation of any skin breakdown or irregularity when the patient was discharged from the facility.

• Brand Name: 3M¿ CAVILON¿ NO STING BARRIER FILM
• Common Device Name: CAVILON NO STING BARRIER FILM
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 9473677
• Report Number: 2110898-2019-00147
• Device Sequence Number: 2708529
• Product Code: KMF
• UDI-Device Identifier: 30707387782376
• UDI-Public: 30707387782376
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K955103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3344ENS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/16/2019
• 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: VAC ULTRA THERAPY DEVICE; VERAFLO¿ CHOICE DRESSING
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR