Nouvelle déclaration d'incident
No de la demande: 2023-5805
Numéro de référence du titulaire d'homologation: 2023-CA-000371 and 2023-CA-000372 (linked cases)
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 29930 ARLA No de la demande d'homologation EPA No d'homologation.
Nom du produit: Hartz UltraGuard OneSpot Flea and Tick Cat Drops (non-specific)
Oui
Inconnu
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
Domestic Mediumhair
1
Homme
6
13.6
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 14-Aug-2023, a 6 year old, approximately 13.6 kilogram, neutered, male, Domestic Mediumhair cat, in unknown condition, with a concomitant medical condition of fleas, was administered 1 tube of Hartz UltraGuard OneSpot Flea and Tick Cat Drops (non-specific) (S Methoprene) via the topical route by the animal owner. This was a first time use. On 21-Aug-2023, the cat developed seizures and died. The cat was not evaluated by a veterinarian, no treatment was performed, and no further information was received.
Mort
Assessment: S-methoprene has a very wide margin of safety in cats following topical application and is not known to cause seizures and death. Even if ingested from the application site only mild GI upset would be expected. Also, signs did not begin until 1 week after application, which is not consistent with the product profile. If this cat truly weighed 30 pounds, it would be morbidly obese which can lead to many medical issues including diabetes and more. Other causes including underlying cardiac, neurological, and metabolic disease, unknown trauma, and toxin exposure should also be considered. Since no veterinary evaluation or diagnostics, including necropsy, were performed the relationship between product use and outcome is inconclusive. 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.
Propriétaire de l'animal
Cat / Chat
Domestic Shorthair
1
Homme
4
4.5
kg
Cutanée
>3 days <=1 wk / >3 jours <=1 sem
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 14-Aug-2023, a 4 year old, approximately 4.5 kilogram, neutered, male, Domestic Shorthair cat, in unknown condition, with a concomitant medical condition of fleas, was administered 1 tube of Hartz UltraGuard OneSpot Flea and Tick Cat Drops (non-specific) (S Methoprene) via the topical route by the animal owner. This was a first time use. On 28-Aug-2023, the cat developed vocalizing, seizures and died. The cat was not evaluated by a veterinarian, no treatment was performed, and no further information was received.
Mort
Assessment: S-methoprene has a very wide margin of safety in cats following topical application and is not known to cause seizures and death. Even if ingested from the application site only mild GI upset would be expected. Also, signs did not begin until 2 weeks after application, which is not consistent with the product profile. Other causes including underlying cardiac, neurological, and metabolic disease, severe flea-bite anemia, unknown trauma, and toxin exposure should also be considered. Since no veterinary evaluation or diagnostics, including necropsy, were performed the relationship between product use and outcome is inconclusive.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.