New incident report
Incident Report Number: 2020-0587
Registrant Reference Number: 2019-US-029792
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: UNITED STATES
Prov / State: PENNSYLVANIA
PMRA Registration No. PMRA Submission No. EPA Registration No. 2724-803-270
Product Name: Adams Flea and Tick Spray for Cats and Dogs
Liquid
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
Domestic Shorthair
1
Female
0.33
2.5
lbs
Skin
Unknown / Inconnu
<=30 min / <=30 min
System
Persisted until death
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 28-Oct-2019, the animal owner applied the product to the cat to treat existing fleas. During product application, the cat developed dyspnea. Approximately 3-4 hours after application this cat appeared unresponsive, lethargic, and limp to the animal owner. A few hours after these signs developed this cat was evaluated by a veterinarian. This cat was hypothermic and treated with warming measures and IV fluids. The animal owner elected to bring the cat home for monitoring and declined ongoing medical treatment and hospitalization. On 30-Oct -2019 the cat developed a slow heart rate, had urinary and fecal incontinence, anorexic and adipsic. The veterinarian was unable to provide a diagnosis for the cat's symptoms to the animal owner but did not think that the product was the cause. On 7-Nov-2019 the animal owner reported that this cat had died. According to the animal owner the veterinarian thought the clinical signs may have been due to rabies (the pets in the household were not fully vaccinated) but testing for rabies was negative. Three other cats and one dog were also treated with the product in this household at the same time. The other 2 cats and 1 dog remained asymptomatic. The deceased cat and other symptomatic cat were placed together in a kennel following treatment. The other animals were separated following treatment. Animal owner had used the product previously on their pets without development of symptoms.
Death
Assessment: This product has a wide margin of safety when applied as labeled. The active ingredients are present in low concentration and are poorly absorbed across intact skin following topical use. If ingested, minor oral or gastric irritation may occur and result in signs including hypersalivation and vomiting. If inhaled, transient cough or respiratory irritation may occur. The type and severity of clinical signs including this cat's death are not expected from this product's use. It is noted that prior use of the product did not result in adversity and three other treated pets in the home remained asymptomatic. Also, the treating veterinarian reportedly did not suspect the product as the cause of the cat's signs. Other causes for the clinical signs including exposure to additional products, infection, feline asthma, congenital disease, cardiac disease, and malnutrition should be considered. Reports directly from the veterinarian and necropsy could have provided further information, but is not available and / or was not performed. 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.