Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-3169

2. Registrant Information.

Registrant Reference Number: ProPharma Group case#: 1-44173727

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.

19-MAY-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)

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PMRA Registration No. 30735      PMRA Submission No.       EPA Registration No.

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

• 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).

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Miniature Schnauzer

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12.5

7. Weight (provide a range if necessary )

11

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

• Renal System
  • Symptom - Inappropriate urination

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

1-43905182 - The reporter, a veterinarian, indicated a patient was exposed to an insecticidal spot-on product containing the active ingredient D-phenothrin. The reporter stated the pet owner applied the product to her 12.5-year-old, 11-pound, male, miniature schnauzer dog for the first time on 01-APR-2016, and for the second time on 01-MAY-2016, 16 days prior to initial contact with the registrant. The pet owner brought the dog to the reporter on an unknown date before initial contact because the dog was urinating all over the house. The reporter was conducting lab tests, but didnt think the symptoms were related to the product. The reporter was advised that this is not an expected reaction to application of the product and to look for other potential causes. No follow-up was attempted. No additional information is available.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here