Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2257

2. Registrant Information.

Registrant Reference Number: 2019-CA-000019

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

Address: 400 Plaza Drive

City: Seacaucus

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-MAY-19

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

20-JAN-19

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. 29930      PMRA Submission No.       EPA Registration No.

Product Name: Hartz UltraGuard One Spot Flea and Tick Drops Spot-on

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

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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).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.9

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

<=30 min / <=30 min

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Salivating excessively

• Nervous and Muscular Systems
  • Symptom - Agitation

• General
  • Symptom - Lethargy

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

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?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Euthanised / Euthanasie

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

On 16-May-2019 a pet owner reported that they applied 1 tube of Hartz UltraGuard OneSpot Flea and Tick Cat Drops (S Methoprene) to the cat on approximately 20-Jan-2019. Immediately after application the cat developed hypersalivation and agitation. The pet owner attempted to wash off the application site with an unknown soap and water. On approximately 21-Jan-2019 the cat developed lethargy. On approximately 27-Jan-2019 the cat developed seizures which continued for three weeks though the frequency of the seizures during that time period was not specified. On approximately 17-Feb-2019 the cat developed muscle weakness in its rear limbs. On 17-Feb-2019 the cat was evaluated by a veterinarian. No diagnostics were performed. The pet owner elected to have the cat humanely euthanized. No necropsy was performed. No further information was received in this case and more information is not expected.

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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

Assessment: This product has a wide margin of safety in cats following dermal application. Even if ingested, only minor oral irritation or GI upset would be expected. Delayed onset seizures and muscle weakness are not expected. Other causes including toxin exposure, underlying neurological disease, infectious diseases, an unknown trauma should be considered in this case. The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.