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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-3097

2. Registrant Information.

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

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

Domestic Animal

4. Date registrant was first informed of the incident.

01-APR-19

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

26-MAR-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)

PMRA Registration No. 25382      PMRA Submission No.       EPA Registration No.

Product Name: Hartz UltraGuard Flea and Tick Collar for Dogs and Puppies

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

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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Mixed Breed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

15.00

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
    • Symptom - Other
    • Specify - Crawling
    • Symptom - Shakiness

12. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

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?

Unknown

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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

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.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

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.