New incident report
Incident Report Number: 2020-2333
Registrant Reference Number: 2019-US-034230
Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Corporation
Address: 400 Plaza Drive
City: Secaucus
Prov / State: New Jersey
Country: USA
Postal Code: 07094-3688
Domestic Animal
Country: UNITED STATES
Prov / State: NEW YORK
PMRA Registration No. PMRA Submission No. EPA Registration No. 2596-153
Product Name: Hartz UltraGuard Rid Flea and Tick Shampoo with Oatmeal for Dogs
Liquid
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Jack Russell Terrier
1
Female
4
14
lbs
Skin
>15 min <=2 hrs / >15 min <=2 h
>30 min <=2 hrs / >30 min <=2 h
System
Persisted until death
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 27-Dec-2019, a 4 year old, approximately 14 pound, intact, female, Jack Russell Terrier dog, in unknown condition, with no known concomitant medical condition, was administered 1 dose of Hartz UltraGuard Rid Flea and Tick Shampoo with Oatmeal for Dogs (Phenothrin) via the topical route by the animal owner. Within 32 minutes of product administration, the dog developed lethargy. Approximately 1 hour post administration, the dog died at home. No necropsy had been performed.
Death
Assessment: The active ingredient in this product is present in low concentration and has a wide margin of safety in dogs. The owner indicated that similar products had been used on the dog in the past without adversity. Sudden death is not anticipated after use and other causes should be considered including but not limited to underlying cardiac disease and unknown trauma. 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.