New incident report
Incident Report Number: 2020-2282
Registrant Reference Number: 2019-CA-000112 and 2019-CA-000113 (linked cases)
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: CANADA
Prov / State: ONTARIO
PMRA Registration No. 30730 PMRA Submission No. EPA Registration No.
Product Name: Hartz UltraGuard Pro Drops for Dogs 14 - 28 kg
PMRA Registration No. 25382 PMRA Submission No. EPA Registration No.
Product Name: Hartz UltraGuard Plus Flea and Tick Collar for Dogs and Puppies
PMRA Registration No. 30731 PMRA Submission No. EPA Registration No.
Product Name: Hartz UltraGuard Pro Drops for Dogs Over 28 kg
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Border Collie
1
Male
5
46
lbs
Skin
Unknown / Inconnu
>24 hrs <=3 days / >24 h <=3 jours
System
Unknown / Inconnu
No
No
Unknown/Inconnu
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01-Jul-2019, a 5 year old, 46 pound, neutered, male, Border Collie dog, in unknown condition, with no known concomitant medical condition, was administered 1 tube of Hartz UltraGuard Pro Drops for Dogs 14 - 28 kg (Phenothrin / S Methoprene) via the topical route by the animal owner. On approximately 02-Jul-2019, the dog exhibited what the animal owner believes to be two seizures. The first seizure was not witnessed but a loud noise was heard. After the animal owner witnessed the dog's seizure, they bathed the dog with liquid dish soap multiple times for product removal. On approximately 28-Aug-2019, the dog was administered 1 collar of Hartz UltraGuard Plus Flea and Tick Collar for Dogs and Puppies (Tetrachlorvinphos / S Methoprene) via the topical route by the animal owner. On approximately 23-Sep-2019, the dog exhibited another seizure. The collar was removed and the application site was washed with liquid dish soap. The dog had not been evaluated by a veterinarian and no treatment had been performed. Veterinary evaluation was recommended to rule out other potential causes for the seizures. No further information was received in this case.
Moderate
Assessment: Seizures are not anticipated following use of either product. Both are considered to have a wide margin of safety in dogs and have poor systemic absorption across intact skin. The development of a seizure several weeks after application of the collar is especially indicative that other causes are more likely including idiopathic epilepsy considering the age and breed of the dog. 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 can not 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.
Animal's Owner
Dog / Chien
Siberian Husky/ Labrador Retriever
1
Male
5
110
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>24 hrs <=3 days / >24 h <=3 jours
System
Unknown / Inconnu
No
No
Unknown/Inconnu
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01-Jul-2019, a 5 year old, 110 pound, neutered, male, Siberian Husky/Labrador Retriever crossbred dog, in unknown condition, with no known concomitant medical condition, was administered 1 tube of Hartz UltraGuard Pro Drops for Dogs Over 28 kg (Phenothrin / S Methoprene) via the topical route by the animal owner. On approximately 28-Aug-2019, the dog was administered 1 collar of Hartz UltraGuard Plus Flea and Tick Collar for Dogs and Puppies (Tetrachlorvinphos / S Methoprene) via the topical route by the animal owner. On approximately 31-Aug-2019, the dog developed application site pruritus and the fit of the collar was adjusted by the animal owner. On approximately 11-Sep-2019, the collar was removed and hair thinning at the application site was observed. The application site was washed with liquid dish soap by the animal owner. The dog had not been evaluated by a veterinarian, no treatment had been performed and the clinical sign continued. No further information was received in this case.
Minor
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 can not 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.