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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-6271

2. Registrant Information.

Registrant Reference Number: ProPharma Group case:# 1-45715216

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.

26-SEP-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

25-SEP-16

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. 25620      PMRA Submission No.       EPA Registration No.

Product Name: HARTZ ULTRAGUARD FLEA & TICK COLLAR FOR DOGS

  • Active Ingredient(s)
    • TETRACHLORVINPHOS

PMRA Registration No. 30734      PMRA Submission No.       EPA Registration No.

Product Name: HARTZ ULTRAGUARD FLEA & TICK TREATMENT FOR DOGS AND PUPPIES WEIGHING 1

  • 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).

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Mixed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

50

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Difficulty getting up
    • Symptom - Shaking

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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

1-45715216- The reporter, a pet owner, indicated her dog was exposed to an insecticidal spot-on product containing the active ingredient (D)-phenothrin, and an insecticidal collar containing the active ingredient tetrachlorvinphos. Four days before the day of initial contact with the registrant, the reporter applied a dose of the spot-on product to her 4-year-old, 50-pound, male, mixed breed dog. One day before the day of initial contact with the registrant the reporter applied the collar to the dog. As soon as the collar was applied, the dog laid down on the floor and would not get up. On the day of initial contact, the reporter moved the dog to a different room and he would still not get up, but then started shivering. The reporter was advised that this is not an expected reaction to the product and she should bathe the dog to remove the product. If the symptoms persist, she should seek veterinary attention. Two follow-up calls were attempted and voicemails were left, but the reporter did not respond. 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

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Mixed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13.5

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

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Difficulty getting up
    • Symptom - Shaking

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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

1-45715216- The reporter, a pet owner, indicated her dog was exposed to an insecticidal spot-on product containing the active ingredient (D)-phenothrin, and an insecticidal collar containing the active ingredient tetrachlorvinphos. Four days before the day of initial contact with the registrant, the reporter applied a dose of the spot-on product to her 13.5-year-old, 15-pound, female, mixed breed dog. One day before the day of initial contact with the registrant the reporter applied the collar to the dog. As soon as the collar was applied, the dog laid down on the floor and would not get up. On the day of initial contact, the reporter moved the dog to a different room and she would still not get up, but then started shivering. The reporter was advised that this is not an expected reaction to the product and she should bathe the dog to remove the product. If the symptoms persist, she should seek veterinary attention. Two follow-up calls were attempted and voicemails were left, but the reporter did not respond. 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