FDA Adverse Event Injury Summary report: N

3M CAVILON NO STING BARRIER FILM PUMP

MDR report key: 2170731 · Received July 12, 2011

Report

Report Number: 2110898-2011-00092
Event Type: Injury
Date Received: July 12, 2011
Date of Event: December 8, 2010
Report Date: January 31, 2011
Manufacturer: 3M HEALTH CARE
Product Code: KMF
PMA / PMN Number: K955103
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

METHOD - (TESTING NOT PERFORMED). RESULTS - (PRODUCT NOT RETURNED). CONCLUSIONS - (NO EVAL WILL BE PERFORMED). DEVICE OR LOT CODE NOT PROVIDED TO MFR FOR EVAL. COMPLAINT TYPE WILL BE MONITORED.

Description of Event or Problem · 1

HEALTH AND SECURITY OFFICER FOR THE (B)(6) HOSPITAL CONTACTED 3M (B)(4), ADVISING THAT A NURSE ON THE SURGICAL UNIT EXPERIENCED AN ALLERGIC REACTION TO CAVILON NO STING BARRIER FILM (NSBF). DURING PT CARE, THE NURSE SPRAYED CAVILON NSBF ON THE PT AND IT IS BELIEVED THAT SHE HAD INHALED SOME OF THE SPRAY. THE NURSE HAD DIFFICULTY BREATHING AND WENT TO THE EMERGENCY DEPT; OXYGEN WAS ADMINISTERED. THE NURSE HAS RETURNED TO WORK FOLLOWING THE INCIDENT. ALLERGIST CONSULTED AND HAS REQUESTED ADDITIONAL PRODUCT INFO RELATING TO COMPOSITION AND PROPELLANT. THE 3M CONFIRMED THAT THERE IS NO PROPELLANT IN CAVILON NSBF; THE DELIVERY SYSTEM IS A MANUAL SPRAY PUMP, NOT AN AEROSOL. THE MATERIAL SAFETY DATA SHEET WAS PROVIDED FOR CAVILON NSBF WHICH OUTLINES EFFECTS OF INHALATION. ADDITIONAL INFO WAS PROVIDED REGARDING 3M'S RESPIRATORY EXPOSURE ASSESSMENTS FOR VOLATILE COMPONENTS (ISOOCTANE AND HEXAMETHYLDISILOXANE) RELATING TO SAFETY DURING PRODUCT USE TO BOTH PTS AND HEALTH CARE WORKERS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	3M CAVILON NO STING BARRIER FILM PUMP	880.5090 LIQUID BANDAGE	KMF	3M HEALTH CARE	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other