FDA.reportPublic FDA data

MAUDE MDR 7129992

MDR report key
7129992
Report number
2110898-2017-00152
Event key
0
Event type
3
Date of event
2017-11-30
Date received
2017-12-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS KAREN KRENIK, BSN
Address
3M CENTER BUILDING 275-5W-06 2510 CONWAY AVE ST. PAUL MN 55144 US
Phone
651-651-6517
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
13M CAVILON NO STING BARRIER FILMCAVILON NO STING BARRIER FILM3M HEALTH CAREKMF33442020 05 CAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-1901. O; 2. R

Event Narratives#

N

Patient 1

(B)(4). INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING INFORMATION: ....WARNINGS 1. DANGER! EXTREMELY FLAMMABLE! 2. CAVILON NO STING BARRIER FILM IS EXTREMELY FLAMMABLE UNTIL IT HAS COMPLETELY DRIED ON THE SKIN. 3. CAVILON NO STING BARRIER FILM SHOULD ONLY BE APPLIED WHEN NO IGNITION SOURCES OR HEAT-PRODUCING DEVICES ARE IN USE. 4. AVOID USING AROUND FLAMES. 5. USE IN A WELL VENTILATED AREA...... THIS PRODUCT IS LABELED AS EXTREMELY FLAMMABLE. THE CUSTOMER REPORTED A STATIC ELECTRIC SHOCK OCCURRED. THE STATIC DISCHARGE WAS MOST LIKELY THE IGNITION SOURCE FOR THIS REPORTED EVENT. 3M IS STILL INVESTIGATING THE POTENTIAL ROOT CAUSE FOR THIS REPORTED EVENT. A REVIEW OF SIMILAR COMPLAINTS REGARDING STATIC DISCHARGE WAS COMPLETED AND NO TREND WAS SEEN.

D

Patient 1

A PHYSICAL THERAPIST REPORTED SHE VISITED THE HOME OF A (B)(6) MALE PATIENT FOR APPLICATION OF KINESIO THERAPEUTIC TAPE. PRIOR TO TAPING, A 3344 CAVILON NO STING BARRIER FILM WIPE WAS OPENED. A STATIC ELECTRIC SHOCK OCCURRED AS THE PRODUCT WAS ABOUT TO BE APPLIED TO THE PATIENT AND IT IGNITED INTO FLAMES. THE FLAMES WERE EXTINGUISHED VERY QUICKLY. THE PATIENT REPORTEDLY EXPERIENCED A BURN IN THREE AREAS AND INITIALLY APPLIED ALOE FOR TREATMENT. A PHYSICIAN WAS CONSULTED AND THE PATIENT WAS DIAGNOSED WITH A SECOND DEGREE BURN TO HIS RIGHT ANKLE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND SILVADENE CREAM WAS BEING USED FOR TREATMENT.