Nouvelle déclaration d'incident
No de la demande: 2020-3425
Numéro de référence du titulaire d'homologation: 2020-CA-000246
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 un animal domestique
Pays: CANADA
État: NOVA SCOTIA
ARLA No d'homologation 30734 ARLA No de la demande d'homologation EPA No d'homologation.
Nom du produit: Hartz UltraGuard Flea and Tick Drops for Dogs 14 - 28 kg
Oui
Inconnu
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Labrador Retriever
1
Homme
8
27.2
kg
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>3 days <=1 wk / >3 jours <=1 sem
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 31-Mar-2020, a 8 year old, approximately 27.2 kg, neutered, male, Labrador Retriever dog, in unknown condition, with concomitant medical condition of fleas, was administered 1 tube of Hartz UltraGuard Flea and Tick Drops for Dogs 14 - 28 kg (Phenothrin (Sumithrin)) via the topical route by the animal owner. This was a first time use of the product. On 07-Apr-2020 the dog developed multiple seizures and vomiting of unspecified green material. On 23-Apr-2020, the dog exhibited another seizure, lasting 30 minutes and died immediately after. The veterinarian was consulted via phone and suspected the signs were caused by an unknown ingestion. The dog was not evaluated by a veterinarian and no treatment was performed. It is unknown if a necropsy was performed. No further information was received in this case.
Mort
Assessment: This product is considered to have a wide margin of safety in dogs. The active ingredients are poorly absorbed across intact skin and not expected to cause systemic signs like seizures progressing to death. If ingested while wet at the application site, mild GI upset including vomiting may occur, but would be expected to occur within the first day of application and not one week later. Other causes including central nervous system disease (brain tumor, infectious, etc.) and other exposures (bromethalin rodenticide due to vomiting green material) should be considered. The information contained in this report is based on self-reported statements provided to the registrant during telephone interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.