Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0068

2. Registrant Information.

Registrant Reference Number: ProPharma Group case:#1-46284043

Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Corporation

Address: 400 Plaza Drive

City: Sedacaus

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.

16-NOV-16

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

15-NOV-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)

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PMRA Registration No. 30732      PMRA Submission No.       EPA Registration No.

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

• Active Ingredient(s)
  • D-PHENOTHRIN

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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).

1-46284043 - The product is designed to be used on dogs over the age of twelve weeks. The product was applied to an eight-week-old dog.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

American Pit Bull Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.15

7. Weight (provide a range if necessary )

Unknown

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 - Muscle twitching

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Lethargy

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

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

1-46284043 - The reporter, a veterinarian, indicated a dog was exposed to an insecticidal spot-on product containing the active ingredient D-phenothrin. One day before the day of initial contact with the registrant, the reporter indicated the dog's owner applied the product to his 8-week-old, female American Pit Bul terrier dog of unknown weight. The dog s owner indicated the dog was having muscle twitching at an unknown time after application. The dog s owner bathed the dog the same day. On the day of initial contact, the reporter indicated the dog had vomited and is lethargic, but has no other symptoms. The reporter was advised the dog was too young to have the product applied and the symptoms may be from an overdose. The reporter was advised to bath the dog again, then treat the symptoms as needed. No follow-up was attempted. No additional information was available.

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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