New incident report
Incident Report Number: 2020-1493
Registrant Reference Number: 2020-US-003462
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: FLORIDA
PMRA Registration No. PMRA Submission No. EPA Registration No. 2724-803-270
Product Name: Adams Flea and Tick Spray
Liquid
Yes
Unknown
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Dog / Chien
German Shepherd Dog
3
Unknown
0.12
Unknown
Skin
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
System
Persisted until death
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 1-March-2020 an unidentified person other than the animal owner applied this product dermally to a litter of 8 puppies to treat fleas. Three of them died and are included in this report. The puppies developed symptoms on 2-March-2020. One puppy died 2-March-2020, the second died 3-March-2020, and the third died 4-March-2020. No further information is available.
Death
Assessment: This product has a wide margin of safety and is labeled to be used on dogs and puppies 10 weeks of age or older. Even though the puppies treated in this case were below the labeled age, the severity of the clinical signs seen with these puppies is not expected. If the puppies had licked the product off one another and ingested some, this product can cause mild GI irritation resulting in self-limiting hyper-salivation, vomiting, or diarrhea. Given that multiple puppies in the same litter are symptomatic, etiologies such as infection and environmental exposure should be considered. Possible causes for the symptoms and death seen include infection (parvo-virus for example), parasites, malnutrition or poor nutrition, and dietary indiscretion or toxicity. Veterinary evaluation and necropsy may have provided further information in this case but was not pursued. 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.