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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-6264

2. Registrant Information.

Registrant Reference Number: ProPharma Group case:# 1-45488730

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.

06-SEP-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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. 30732      PMRA Submission No.       EPA Registration No.

Product Name: HARTZ ULTRAGUARD FLEA & TICK TREATMENT FOR DOGS AND PUPPIES WEIGHING 2

  • Active Ingredient(s)
    • D-PHENOTHRIN

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).

1-45488730 - The product was initially applied to the dog twenty-two days before the day of initial contact with the registrant, then another dose was applied to the dog four days before the day of initial contact with the registrant. This is a span of eighteen days. The recommended dosing interval is thirty days.

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

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
  • Skin
    • Symptom - Other
    • Specify - Warm to the touch
    • Symptom - Erythema
  • Nervous and Muscular Systems
    • Symptom - Muscle twitching

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

1-45488730 - The reporter, a pet owner, indicated her dog was exposed to an insecticidal spot-on product containing the active ingredient D-phenothrin. Twenty-two days before the day of initial contact with the registrant, the reporter applied a single dose of the product to her 10-pound, 2-year-old, male, Shih Tzu dog. The dog had a single episode of vomiting at an unknown date after this application. Four days before the day of initial contact with the registrant the reporter applied another dose of the product to the dog. Within two to three days, the dog developed vomiting, anorexia, lethargy, muscle twitching in his rear legs, and felt warm to the touch with red skin. The caller was informed that the dosing interval of the product should be every thirty days, but she had reapplied it after only eighteen days leading to a possible overdose. The reporter was instructed to bathe the pet and seek veterinary care for him. On follow-up call two days later, the reporter indicated she had not sought veterinary care for the dog due to financial concerns. The dogs skin was still pink and he was not eating well, but the reporter believed he was a more normal skin temperature. The reporter was again advised to seek veterinary care for the dog. No additional information is available.


To be determined by Registrant

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

Minor

19. Provide supplemental information here