3M? CAVILON? NO STING BARRIER FILM N/A 3344E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-27 for 3M? CAVILON? NO STING BARRIER FILM N/A 3344E manufactured by 3m Health Care.

Event Text Entries

[137309831] This complaint is for a flammability event that occurred in october 2018. 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. There is flammability information in the cavilon no sting barrier film catalog number 3344e ifu and a flame symbol on each individual pouch. For this application, cavilon no sting barrier film catalog number 3344e is provided non-sterile to kci as a component of their kit. Cautery was the ignition source for this event.
Patient Sequence No: 1, Text Type: N, H10


[137309833] A distributor recently reported that approximately 4 months ago, 3m cavilon? No sting barrier film was applied to a patient's skin prior to placement of a wound vac device. A physician reportedly used a bovie cautery device to stop a bleeder following application of the cavilon no sting barrier film. The distributor reported a small flash fire occurred. The patient was reportedly not injured in this reported event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2110898-2019-00032
MDR Report Key8375519
Report SourceDISTRIBUTOR
Date Received2019-02-27
Date of Report2019-02-27
Date of Event2018-10-22
Date Mfgr Received2019-02-22
Date Added to Maude2019-02-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDIANNE GIBBS
Manufacturer Street3M CENTER BUILDING 275-5W-06
Manufacturer CityST. PAUL MN 55144
Manufacturer CountryUS
Manufacturer Postal55144
Manufacturer Phone6517379117
Manufacturer G13M HEALTH CARE LIMITED
Manufacturer StreetDERBY ROAD
Manufacturer CityLOUGHBOROUGH, LEICESTERSHIRE LE115SF
Manufacturer CountryUK
Manufacturer Postal CodeLE11 5SF
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3M? CAVILON? NO STING BARRIER FILM
Generic NameCAVILON NO STING BARRIER FILM
Product CodeKMF
Date Received2019-02-27
Model NumberN/A
Catalog Number3344E
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer3M HEALTH CARE
Manufacturer Address2510 CONWAY AVE ST. PAUL MN 55144 US 55144


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-02-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.