New incident report
Incident Report Number: 2019-3097
Registrant Reference Number: 2415311
Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Corporation
Address: 400 Plaza Drive
City: Seacaucus
Prov / State: New Jersey
Country: USA
Postal Code: 07094-3688
Domestic Animal
Country: CANADA
Prov / State: SASKATCHEWAN
PMRA Registration No. 25382 PMRA Submission No. EPA Registration No.
Product Name: Hartz UltraGuard Flea and Tick Collar for Dogs and Puppies
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Mixed Breed
1
Male
10
15.00
lbs
Skin
>24 hrs <=3 days / >24 h <=3 jours
>8 hrs <=24 hrs / > 8 h < = 24 h
System
>2 hrs <=8 hrs / > 2 h < = 8 h
No
No
Unknown
Fully Recovered / Complètement rétabli
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
4/1/2019 3:43:17 PM A pet owner reported they applied the collar to the dog on approximately March 25, 2019. On March 26, 2019, the dog developed shaking, tremoring, crawling instead of walking, anorexia, and vocalization. The owner then removed the collar. Within 2 hours, the dog's signs resolved. The owner reapplied the collar and within 30 minutes the same signs developed. The owner removed the collar again and within 2 hours the dog's signs resolved. The collar was not reapplied to the dog. The same version of the collar had been used on the dog numerous times in the past without adversity. Monitoring at home for further clinical signs was recommended. No further information was received in this case.
Moderate
The signs reported in this case are not anticipated with labeled use of the product. The product had been used on the dog multiple times previously without issue. The active ingredients are considered to have a wide margin of safety in dogs following dermal application. Given the quick resolution of signs after removal of the collar it is suspected that the signs were likely related to a behavioral reaction to having the collar applied and not due to true central nervous system signs and systemic toxicity. 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.