Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1026

2. Registrant Information.

Registrant Reference Number: ProPharma Group case:# 1-51382796

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.

16-FEB-18

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

12-FEB-18

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.       PMRA Submission No.       EPA Registration No. 2596-174

Product Name: HARTZ ULTRAGUARD PRO TOPICAL FLEA&TICK PREV FOR CATS&KITTENS >12 WEEK

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 3.6 %
  • ETOFENPROX
    • Guarantee/concentration 40 %

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7. b) Type of formulation.

Liquid

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

Cat / Chat

3. Breed

Persian

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.75

7. Weight (provide a range if necessary )

8

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Inappropriate defecation

• Renal System
  • Symptom - Inappropriate urination

• General
  • Symptom - Subdued

• Nervous and Muscular Systems
  • Symptom - Seizure
  • Symptom - Muscle tremors

• Blood
  • Symptom - Leukocytosis

• Renal System
  • Symptom - Other
  • Specify - abnormal kidney values

• General
  • Symptom - Lethargy

12. How long did the symptoms last?

Persisted until death

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

Died

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

1-51382796 - The reporter, a pet owner, indicated her cat was exposed to an insecticidal spot-on product containing the active ingredients (S)-methoprene and etofenprox. Four days before the day of initial contact with the registrant, the reporter applied the product to her 9-month-old, 8-pound, male, Persian cat. Approximately 1.5 hours after application, the cat urinated and defecated on the reporter¿¿¿¿¿¿s bed but otherwise seemed normal. At that time, the reporter bathed the pet. Three days before the day of initial contact with the registrant, the cat seemed subdued. Two days before the day of initial contact, the cat had muscle tremors and a seizure. One day before the day of initial contact, the reporter brought the cat to a veterinarian where it was found to have an elevated white blood cell count, elevated renal values, and was treated with fluids and sent home. The cat was lethargic once back at home. The reporter indicated she found the cat dead on the morning of the day of initial contact. Necropsy was discussed with the reporter, but it is unknown if this was pursued. 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

Death

19. Provide supplemental information here