Nouvelle déclaration d'incident
No de la demande: 2010-2689
Numéro de référence du titulaire d'homologation: PROSAR 1-22516131
Nom du titulaire (nom légal complet, aucune abbréviation): The Hartz Mountain Corporation
Adresse: 400 Plaza Drive
Ville: Secaucus
État: New Jersey
Pays: USA
Code postal /Zip: 07094-3688
Incident chez l'humain
Pays: UNITED STATES
État: NEW MEXICO
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 2596-125
Nom du produit: UltraGuard Flea and Tick Spray for Dogs
Liquide
Oui
Inconnu
Site: Animal / Usage sur un animal domestique
Inconnu
Autre
Sexe: Femme
Âge: >12 <=19 yrs / >12 <=19 ans
Système
Unknown / Inconnu
Oui
Oui
Inconnu
Non professionnel
Application
Aucun
Peau
<=15 min / <=15 min
>2 hrs <=8 hrs / > 2 h < = 8 h
1-22516131: The reporter called the registrant on 5/6/10 to report an adverse reaction by a (age) year old girl after she was exposed to a flea and tick spray containing the active ingredient Tetrachlorvinphos. According to the reporter (the patient¿s grandmother), the patient was exposed to multiple products 24-48 hours prior to the onset of symptoms. On 5/3/10, she was exposed to multiple industrial pesticides while cleaning out dog kennels at her workplace. The following day (5/4), the patient was exposed to a strong epoxy glue smell all day while assisting her father in applying tile flooring. Later in the day on 5/4, the patient bathed her dog (product unknown) and then applied the Tetrachlorvinphos-based spray, rubbing the spray into the dog¿s coat with her hands. The reporter did not know if the patient had washed her hands afterwards. The reporter believed the product was dry before the patient went to bed with the dog. The following morning (5/5), the patient awoke and had a seizure. An ambulance took the patient to the hospital to be evaluated; she was released from the hospital and then experienced another seizure. At the time of the call the patient had returned to the hospital, and the attending physicians were calling the episodes "seizures". A diagnosis was still open. During the call the safety profile of the product was discussed. A recommendation was made to continue to work with the physicians. Overexposure to a more concentrated form of the active ingredient could cause neurological symptoms; however, the low concentration in the product (1.08%) and the brief dermal exposure would not be expected to cause anything more significant than minor dermal irritation. The reporter requested and was faxed an MSDS for the product. She indicated her granddaughter had used the Hartz product for years without any problems. A follow-up call on 5/9/10 revealed that the patient had been released from the hospital and was doing much better. No additional seizures had developed. The cause of the seizures was still in question; the family was waiting for results of some blood tests. No additional information is available.
Majeure
The patient was exposed to multiple products 24-48 hours prior to the onset of symptoms. On 5/3/10, she was exposed to multiple industrial pesticides while cleaning out dog kennels at her workplace. The following day (5/4), the patient was exposed to a strong epoxy glue smell all day while assisting her father in applying tile flooring. Later in the day on 5/4, the patient bathed her dog (product unknown) and then applied the Tetrachlorvinphos-based spray, rubbing the spray into the dog¿s coat with her hands. The reporter did not know if the patient had washed her hands afterwards. The reporter believed the product was dry before the patient went to bed with the dog. Symptoms developed the following morning (5/5/10).