FDA Adverse Event Injury Summary report: N

NUPREP GEL

MDR report key: 833523 · Received March 29, 2007

Report

Report Number: 1718791-2007-00005
Event Type: Injury
Date Received: March 29, 2007
Date of Event: March 7, 2007
Report Date: March 29, 2007
Manufacturer: D.O. WEAVER AND CO
Product Code: GYB
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INFO IN THIS REPORT BASED ON INITIAL CONTACT. MULTIPLE ATTEMPTS TO ACQUIRE FURTHER INFO FROM REPORT WERE NOT SUCCESSFUL. ATTEMPT TO GATHER INFO FROM INDIVIDUAL IN LOSS MGMT DEPT REGARDING INCIDENT ALSO UNSUCCESSFUL. CALLS WERE NOT RETURNED TO US. WE COULD NOT REACH A CONCLUSION REGARDING THE INVOLVEMENT OF OUR PRODUCT IN THIS INCIDENT.

Description of Event or Problem · 1

INPATIENT UNDERWENT AN EEG EXAM IN THE NEUROLOGY DEPT. OF THE HOSP. AFTER THE TEST WAS COMPLETED...A TIME OF ABOUT 45 MINUTES...THE PT WENT IN TO A GENERAL MALAISE AND "SHOCK" CONDITION IN WHICH HIS TONGUE SWELLED AND BECAME OBSTRUCTIVE. HIS BREATHING WAS IRREGULAR. THE HOSP RAPID RESPONSE TEAM WAS SUMMONED AND HE WAS ADMINISTERED EPINEPHRINE AND DEXAMETHASONE AS PART OF THE RESPONSE TEAM. HE WAS STABILIZED AND RETURNED TO HIS INPATIENT BED. NUPREP WAS ONE OF THE PRODUCTS USED DURING THE EEG THAT COULD HAVE PRECIPITATED AN ANAPHYLACTIC TYPE RESPONSE. IT IS UNK AND UNDETERMINED WHAT THE CAUSE OF THE CONDITION MIGHT HAVE BEEN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NUPREP GEL	SKIN PREP GEL	GYB	D.O. WEAVER AND CO	10-30	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	YR		Life Threatening\| R