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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7625

2. Registrant Information.

Registrant Reference Number: ProPharma Group case:# 1-45909435

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.

13-OCT-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. 30731      PMRA Submission No.       EPA Registration No.

Product Name: HARTZ ULTRAGUARD PRO FLEA & TICK TREATMENT FOR DOGS AND PUPPIES WEIGHI

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

1-45909435 - The reporter also used a non-company anti-fungal shampoo. The active ingredient and manufacturer are unknown.

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

Golden Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

85

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

  • Skin
    • Symptom - Rash
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • Skin
    • Symptom - Erythema
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
  • General
    • Symptom - Fever
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
    • Symptom - Difficulty getting up
    • Symptom - Shaking
  • Skin
    • Symptom - Pruritus

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

1-45909435 - The reporter, a pet owner, indicated her dog was exposed to an insecticidal spot-on product containing the active ingredients (S)-methoprene and D-phenothrin. Approximately one week before the day of initial contact with the registrant, the reporter applied the product to her 8-year-old, 85-pound, female Golden Retriever dog. Within a couple of hours of application, the dog started scratching all over. Two days after application, the dog developed a rash on her stomach, lethargy, and stopped eating. One day before the day of initial contact with the registrant, the dog developed erythema all over her body, vomiting, diarrhea, fever, muscle tremors, shaking, and difficulty getting up. The reporter has not sought veterinary care for the dog, but spoke to a veterinarian over the phone who recommended washing the pet in an anti-fungal shampoo which the reporter did. The shampoo seemed to help with some of the itching. The reporter was advised to seek immediate veterinary evaluation as the pets symptoms sound serious, and would not be expected from normal product use. Follow-up was attempted five and six days after the day of initial contact with the registrant, and voicemails were left requesting an update on the dog. No additional information is available.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here