New incident report
Incident Report Number: 2016-7143
Registrant Reference Number: 160132062
Registrant Name (Full Legal Name no abbreviations): Wellmark International
Address: 100 Stone Road West, Suite 111
City: Guelph
Prov / State: Ontario
Country: Canada
Postal Code: N1G5L3
Domestic Animal
Country: CANADA
Prov / State: ONTARIO
PMRA Registration No. 31985 PMRA Submission No. EPA Registration No.
Product Name: Zodiac InfeStop Topical Solution for Dogs Over 25 kg
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Labrador Retriever Mix
1
Female
4.0
85.0
lbs
Skin
Unknown / Inconnu
>24 hrs <=3 days / >24 h <=3 jours
System
Unknown / Inconnu
Yes
Unknown
Not recovered / Non rétabli
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On August 27, 2016 the dog developed symptoms. On August 29, 2016 the dog developed anorexia, vomiting, and polydipsia. On September 3, 2016 the dog developed pale mucous membrane color and icterus (do not know how severe this is). Later that day, the owner took the dog to the veterinarian, where a chemistry profile, complete blood count, radiographs were completed, and antibiotics (sent home) were prescribed. On September 4, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated imidacloprid is an insecticide that has a low toxicity to mammals. The APSS veterinarian also stated ingestion of this agent may cause mild gastrointestinal upset. The APSS veterinarian finally stated no observed effect level (NOEL) in dogs is 50 milligrams per kilogram (mg/kg). The APSS technician relayed to the owner the APSS veterinarian stated this product does not get absorbed systemically and we would not expect any organ damage from this product. The APSS technician recommended taking the dog back to the veterinarian (as signs are continuing), having the veterinarian call for information (we would like to speak with the veterinary clinic and discuss treatment with them), and calling back with questions.
Major
The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On September 6, 2016 the owner returned the APSS's follow up call. The owner stated that the dog was still displaying all clinical signs and she had an appointment with the attending veterinarian that afternoon. The APSS technician asked that she either call the APSS back with an update or have the attending veterinarian call if they would like to discuss the case. At this time, no updates have been obtained.