Nouvelle déclaration d'incident
No de la demande: 2013-3241
Numéro de référence du titulaire d'homologation: 2013AM146
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 77 Belfield Rd
Ville: Toronto
État: ON
Pays: Canada
Code postal /Zip: M9W 1G6
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. Inconnu
Nom du produit: Advantage II
Liquide
Oui
Inconnu
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
unknown
1
Inconnu
0.5
Inconnu
Cutanée
Unknown / Inconnu
>2 hrs <=8 hrs / > 2 h < = 8 h
Système
Persisted until death
Oui
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
8/19/2011 12:34:25 PM Caller states that she applied the product 2 days ago and within 2 hrs, the cat developed ataxia and confusion. He stopped eating and drinking and soiled himself. The cat is being tx at the Vet currently and the Vet has made a statement that the rxn is directly related to the product. Caller is a Nurse Practitioner and does research for pharmaceuticals. Caller states that the cat is going to die and that the death is directly attributed to the product. 8/19/2011 12:48:27 PM: Owner did not have a UPC or EPA, gave the CVT the name and the lot number. Packaging is at the DVM. O purchased the product from (name)t. Owner noticed some lethargy 2 hours after the application. The caller applied the product late in the evening and in the a.m. the pet didn't eat or drink much. The owner then used a medicine dropper to force fluids. That evening the pet was increasingly listless and started vomiting. The package is at the DVM office. Per the owner the DVM indicated that he could not save the pet and that the product had poisoned him. She is calling to report the adverse event and is asking for financial reimbursement for medical expenses. Client wants financial reimbursement for medical care. 8/23/11 - The veterinarian said that the cat came in first thing in the morning on 8/19/11. The cat was in a coma and the cat had constriction of the pupils. The cat was treated with intravenous fluids, atropine every four hours and hyperbag oxygen. 10 hours later the cat passed away. The cat has an unknowm medical history and this was the first time the kitten was seen by the veterinarian. The body will be sent in for a necropsy. Update 14.10.2011 Technical assessment: The batch was manufactured according to specification. No deviations that could have led to the complained adverse event occurred. The certificate of analysis is attached to the complaint. Since no complaint sample is available, we cannot perform further investigations. Update 20.10.2011 The necropsy was done on 8/31/11. The necropsy results show pulmonary congestion and edema, mild anemia and intestinal parasitism (roundworms 4+) with a mucoid bloody digesta. Histopathology findings were multifocal chronic suppurative myocarditis, pulmonary edema and parasitic enteritis. No further information is expected.
Mort
Reported signs are not anticipated with appropriate topical product use as inconsistent with pharmaco-toxicological product profile. Though initial lethargy may be a possible side effect, aggravation of signs not anticipated with product use. A necropsy examination revealed pulmonary congestion and edema, mild anemia and myocarditis suggestive of aberrant Toxoplasma migration. The technical revision of the complained batch did not reveal any deviation from the specification. All things considered is a product relation unlikely.