New incident report
Incident Report Number: 2020-2267
Registrant Reference Number: 2019-CA-000074
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: QUEBEC
PMRA Registration No. 30735 PMRA Submission No. EPA Registration No.
Product Name: Hartz UltraGuard Flea and Tick Drops for Dogs Over 28 kg
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Labrador Retriever
1
Male
8
180
lbs
Skin
Unknown / Inconnu
>8 hrs <=24 hrs / > 8 h < = 24 h
System
<=30 min / <=30 min
No
No
Fully Recovered / Complètement rétabli
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 11-Jun-2019, an 8 year old, 180 pound, neutered, male, Labrador retriever dog, in unknown condition, with concomitant medical conditions of lyme disease, was administered 1 tube of Hartz UltraGuard Flea and Tick Drops for Dogs Over 28 kg (Phenothrin) via the topical route by the animal tender. The product had been applied to the dog previously on an unspecified date, without any issues. On 12-Jun-2019, the dog developed shaking and fell over. Within five minutes the clinical signs resolved and the dog recovered without medical intervention. Veterinary evaluation and bathing the dog with liquid dish soap was recommended. No further information was received in this case.
Moderate
Assessment: Paresthesia may occur following topical application of pyrethroid insecticides, like phenothrin. Behavioral changes including shaking may occur if the sensation is distressing to the dog. Altered gait may occur secondary to paresthesia, especially if the dog scratched at the application site and some product transferred to the paws. However, signs in this case resolved after 5 minutes without treatment which is not typical of a paresthesia reaction. The described episode may have been a seizure, which is also not expected following product use. Other causes should be considered in this case including central nervous system disease (brain tumor, infectious causes, idiopathic epilepsy), underlying metabolic disease, and other exposures. 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.