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

Model Number N/A

Device Problem Fire (1245)

Patient Problem Erythema (1840)

Event Date 08/15/2019

Event Type  Injury  

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 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
• Type of Device: CAVILON NO STING BARRIER FILM
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M HEALTH CARE LIMITED; derby road; loughborough, LE11 5SF,; UK LE11 5SF,
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 9473677
• MDR Text Key: 170892800
• Report Number: 2110898-2019-00147
• Device Sequence Number: 1
• Product Code: KMF
• UDI-Device Identifier: 30707387782376
• UDI-Public: 30707387782376
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3344ENS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VAC ULTRA THERAPY DEVICE; VERAFLO¿ CHOICE DRESSING
• Patient Outcome(s): Other
• Patient Age: 63 YR