Nouvelle déclaration d'incident
No de la demande: 2013-4422
Numéro de référence du titulaire d'homologation: 2013-US-07723
Nom du titulaire (nom légal complet, aucune abbréviation): Virbac Animal Health
Adresse: 3200 Meacham Blvd.
Ville: Fort Worth
État: TX
Pays: United States
Code postal /Zip: 76137
Incident chez un animal domestique
Pays: UNITED STATES
État: UNKNOWN
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 2382-104
Nom du produit: Preventic Collar for Dogs 18"
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation.
Nom du produit: Advantage Multi to the dog
Autre (préciser)
CollarOui
Autres unités: Collar
Site: Animal / Usage sur un animal domestique
Inconnu
Professionnel de la santé
Dog / Chien
Schnauzer
1
Homme
4.5
22.0
lbs
Cutanée
>8 hrs <= 24 hrs / >8 h <= 24 h
>24 hrs <=3 days / >24 h <=3 jours
Système
Persisted until death
Oui
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 06/04/2013, sponsor was contacted by the animal owner to report an apparent adverse reaction to the PREVENTIC (18/9% Amitraz) Tick Collar for Dogs. According to the attending veterinarian, the dog was seen at the clinic on 04/11/2013 for an annual exam and vaccinations (Rabies, DHLPP). The dog tested positive for Lyme Disease and was started on unspecified doses of Minocycline and administered a Lyme vaccine at that time. On 04/19/2013 the dog presented to the clinic lethargic, depressed, not eating, and had a painful abdomen. The dog tested positive for Pancreatitis and had a barium series performed, as there was some concern of a foreign body. The dog fully recovered and was discharged forty-eighty hours later. On 05/05/2013 the dog returned to the clinic for Lyme and Distemper booster vaccines. The dog was playful at that time, but hesitant to jump up, per the veterinarian. At this time the animal owner purchased the PREVENTIC collar from the clinic. On 05/06/2013 the animal owner applied Advantage Multi to the dog and then on 05/17/2013 the animal owner applied the PREVENTIC collar to the dog for the first time. Approximately twenty-four hours later, the dog became lethargic, could not jump, and was trembling in the rear legs, per the veterinarian. On 05/18/2013 the collar was removed, the dog was bathed, and the dog was seen at the clinic. The clinic performed blood work and the dog's PCV was 36 percent and the dog had a mildly elevated ALT and ALKP. The dog was sent home with unspecified doses of Amoxicillin and pain medication (unspecified NSAID). On 05/20/2013 the dog returned to the clinic with neck pain, trembling, and inappetence. The clinic performed an ACTH stem test which came back inconclusive. The dog was sent home and the animal owner called the clinic to report the dog passed away on 05/21/2013. The veterinarian did not feel the adverse event was related to the PREVENTIC; however, she did promise the animal owner that she would contact all the companies (i.e. vaccines, topicals, oral drugs, etc...) to see if this could be an expected reaction to any of the drug products. The veterinarian indicated that the dog was seen at the clinic back in September 2012 and she had suspected the dog had Lyme disease at that time. No further information is expected.
Mort
Sponsor notes that it is unlikely that the PREVENTIC collar can be associated with the dog's clinical signs and subsequent death, and it is more likely related to complications with the Lyme disease. The attending veterinarian did not think the adverse event was related to the PREVENTIC collar.