New incident report
Incident Report Number: 2016-3029
Registrant Reference Number: 2016-107606
Registrant Name (Full Legal Name no abbreviations): Bayer Inc. Consumer Care
Address: 2920 Matheson Blvd East
City: Mississauga
Prov / State: Ontario
Country: Canada
Postal Code: L4W 5R6
Human
Country: UNITED STATES
Prov / State: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. N/A
Product Name: Product name unknown
Unknown
Unknown
Medical Professional
Sex: Male
Age: Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Unknown
Unknown
Unknown
Unknown / Inconnu
Unknown / Inconnu
Case Description: This case report from UNITED STATES was derived from medical literature on 27-MAY-2016 , article entitled "The toxicity of picaridin containing insect repellent reported to the National Poison Data System.". It refers to a male patient of unspecified age. Trade name of Bayer product was not reported. Case report: This case refers to an adult male patient who had unintentional exposure to DEET (N,N-Diethyl-3-methylbenzamide) anddied. The patient died as a result of the exposure or as a direct complication of the exposure, where the complication was unlikely tohave occurred had the toxic exposure not preceded the complication. Authors comment:In the study one death was identified, an adult male with unintentional exposure to an insect-repellent containing DEET. Publication Abstract:Context: While low toxicity is reported, there are sparse data on the safety of acute picaridin (icaridin) exposures in humans. Objective: The purpose of this study was to review National Poison Data System (NPDS) data regarding ingestion of insect repellents containing picaridin and compare those to insect repellents containing DEET and other insect repellents not containing DEET. Methods: NPDS was queried for single agent human insect repellent ingestions reported between 1 January 2000 and 31 May 2015using the American Association of Poison Control Center generic categories 201048 (Insect Repellents with DEET) and 201049(Insect Repellents without DEET). Picaridin containing product exposures were assessed using PoisindexVR product ID 6744589.Insect repellents of unknown type were not included. Results: 68,429 exposures occurred; 24% were non-DEET-containing products, of which 2% were picaridin- containing products. Among picaridin exposures, 92.9% were managed outside of a health-care facility; there were no reported cases of major effect or death, and only one case of moderate effect. Primary symptoms across all insect repellent exposures included ocular irritation/pain,vomiting, red eye/conjunctivitis, and oral irritation. Treatment primarily included dilution/irrigation/wash. Conclusion: Unintentional ingestion of picaridin-containing and other insect repellents was associated only with minor toxicity and was generally managed outside of a health-care facility. Sender Comments: This case report was derived from medical literature (published report from study) and refers to a male patient of unspecified age who accidentally was exposed to diethyltoluamide and died. DIED, serious due to its fatal outcome, is unlisted in the Reference Safety Information for diethyltoluamide. Cause of death was not provided. In this case, the authors stated that the patient died as a result of the exposure or as a direct complication of the exposure. Considering this information, causality between the reported event and diethyltoluamide cannot be excluded, in a conservative approach.
Death
Trade name of a Bayer product was not reported