New incident report
Incident Report Number: 2023-4157
Registrant Reference Number: 2023-CA-000210 and 2023-CA-000217 (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: ALBERTA
PMRA Registration No. 30733 PMRA Submission No. EPA Registration No.
Product Name: Hartz UltraGuard Flea and Tick Drops for Dogs 6 - 14 kg Spot-on
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Havanese/Yorkshire Terrier crossbred
1
Male
2
6.3
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Unknown/Inconnu
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01-May-2023, a 2 year old, approximately 6.3 kilogram, neutered, male, Havanese/Yorkshire Terrier crossbred dog, in unknown condition, with no known concomitant medical condition, was administered 1 tube of Hartz UltraGuard Flea and Tick Drops for Dogs 6 - 14 kg (Phenothrin (Sumithrin)) via the topical route by the animal owner. On approximately 05-May-2023, the dog developed pruritus and application site self trauma for an unspecified amount of time but recovered the same day. On 11-Jun-2023, the dog was administered 1 tube of Hartz UltraGuard Flea and Tick Drops for Dogs 6 - 14 kg (Phenothrin (Sumithrin)) via the topical route by the animal owner. On 12-Jun-2023, the dog developed agitation, restlessness, application site erythema, application site irritation, and application site burn. The dog was not evaluated by a veterinarian, no treatments were performed, and the clinical signs continued. Bathing the dog with dish soap for product removal, along with monitoring for persistent or worsening signs was recommended. No further information was received.
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 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.