FDA Adverse Event Injury Summary report: N

SURGINE II SURGICAL MASK

MDR report key: 137729 · Received November 24, 1997

Report

Report Number: 1618732-1997-00188
Event Type: Injury
Date Received: November 24, 1997
Date of Event: October 20, 1997
Report Date: November 21, 1997
Manufacturer: TECNOL MEDICAL PRODUCTS, INC.
Product Code: FXX
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: GA, US
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

A NURSE IN THE RECOVERY ROOM, RARELY WEARS A MASK, HOWEVER ON 10/20/97 SHE HAD TO PUT ON A MASK, "FOR 3 MINUTES". "WITHIN SEVERAL HOURS SHE HAD HIVES AROUND HER EYES AND ON HER CHEEKS, AND HER EYES HAD ALMOST SWOLLEN SHUT. SHE HAD NO RESPIRATORY INVOLVEMENT. THEY DID ADMINSITER IV SOLUMADROL IN THE ER TO ALLEVIATE HER SYMPTOMS. SHE IS SUFFERING "NO LONG TERM EFFECTS", AND BACK TO WORK TODAY 10/23.A SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORDS INDICATE NO DEVIATIONS THAT COULD HAVE CONTRIBUTED TO A LATEX REACTION. ALL RAW MATERIALS AND PACKAGING USED IN FACE MASK PRODUCTION ARE FREE OF LATEX. THE MFR'S PROCESSES DO NOT EXPOSE THE PRODUCTS TO ANY LATEX DURING PRODUCTION, STORAGE OR HANDLING. THE MFR'S SUPPORT PERSONNEL CONTACTED ALL SUPPLIERS OF PARTS AND EQUIPMENT THAT COME IN CONTACT OR NEAR THE PRODUCT SURFACES, IE, BELTS, ROLL, FOAM AND TAPES. ALL EQUIPMENT WAS FOUND TO BE LATEX FREE. NO OTHER COMPLAINTS HAVE BEEN FILED FOR THIS MASK REFERING TO A LATEX REACTION AS A RESULT OF WEARING THE MASK. THE INVESTIGATION COULD NOT CONFIRM AN ACTUAL FAILURE OF THE PRODUCT , BUT RATHER AN ISOLATED REACTION OF AN INDIVIDUAL. TRENDS SHALL CONTINUE TO BE MONITORED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SURGINE II SURGICAL MASK	MASK, SURGICAL	FXX	TECNOL MEDICAL PRODUCTS, INC.	NA	7J121406, 7H181037

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Life Threatening