Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2295

2. Registrant Information.

Registrant Reference Number: 2019-CA-000171

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

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

12-NOV-19

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

09-NOV-19

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

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PMRA Registration No. 29282      PMRA Submission No.       EPA Registration No.

Product Name: Hartz UltraGuard Pro Flea and Tick Drops for Dogs Over 30 lbs

• Active Ingredient(s)
  • (S)-METHOPRENE
  • PERMETHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Maltese/Poodle crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

15

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Ataxia
  • Symptom - Restlessness

• Skin
  • Symptom - Erythema
  • Symptom - Inflammation of the skin
  • Symptom - Rash

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On approximately 09-Nov-2019, a 10 year old, 15 pound, neutered, female, Maltese/Poodle crossbred dog, in unknown condition, with concomitant medical conditions of tick attachment and unspecified anal gland issues, was administered a partial tube of Hartz UltraGuard Pro Flea and Tick Drops for Dogs Over 30 lbs (Permethrin, s-methoprene) via the topical route by the animal owner. The product was used extra label due to the weight of the dog and the entire tube was not applied. Thirty minutes post application, the dog exhibited walking sideways (ataxia) and restlessness. On approximately 10-Nov-2019, the dog was bathed using an unspecified amount of an unspecified dog shampoo via the topical route by the animal owner. On 11-Nov-2019 the dog was evaluated by a veterinarian. Anal gland expression was performed and the dog was tested for tick-borne diseases. The pet owner did not disclose use of product to the veterinarian. No treatments were performed. On 12-Nov-2019, the dog exhibited application site erythema, application site swelling and application site rash. The dog was not re-evaluated by a veterinarian, no treatments were performed and the clinical signs continued. Bathing the dog with liquid dish soap twice, and applying a cool compress and vitamin E oil to the application sites was recommended. Veterinary evaluation was recommended if the signs persisted. No further information was received in this case.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

Assessment: Paresthesia may occur following topical application of pyrethroid insecticides, including phenothrin. Behavioral changes including agitation 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. Ataxia related to central nervous system depression is not anticipated. Application site reactions may occur if a dog is sensitive to any of the product ingredients. 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.