Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4158

2. Registrant Information.

Registrant Reference Number: 2023-CA-000218

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.

15-JUN-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

08-JUN-23

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 OneSpot Flea and Tick Cat Drops

• 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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

7.0

kg

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

• Skin
  • Symptom - Pruritus
  • Symptom - Hair loss
  • Symptom - Pruritus
  • Specify - Application site self trauma
  • Symptom - Burns (superficial)
  • Specify - Application site chemical burn
  • Symptom - Lesion
  • Specify - Application site sores
  • Symptom - Red skin
  • Symptom - Lesion
  • Specify - Application site scab

• General
  • Symptom - Insomnia
  • Specify - Unable to sleep

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?

No

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

On 08-Jun-2023, a 4 year old, approximately 7.0 kilogram, Domestic Shorthair cat, of unknown further signalment, in unknown condition, with no known concomitant medical condition, was administered 1 tube of Hartz UltraGuard OneSpot Flea and Tick Cat Drops (S Methoprene) via the topical route by the animal owner. Immediately post-application, the cat developed application site itching (pruritus). On approximately 09-Jun-2023, the cat developed application site hair loss from self trauma, application site redness, application site sores, application site scabs, application site chemical burn and was unable to sleep. On 15-Jun-2023, the event was reported by the treating veterinarian and the signs continued. The cat was prescribed an unknown dose of prednisone to be given to the cat by the animal owner, at a tapering dose for 7 days. Bathing the cat with liquid soap was also recommended to the owner by the veterinarian. It is unknown if the cat was actually bathed. On 16-Jun-2023, the clinical sign of being unable to sleep resolved. The application site itching and application site hair loss improved but continued. The remaining clinical symptoms continued. No further information was received.

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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: S-methoprene has a very wide margin of safety in cats. Sores and burns are not anticipated simply from application of the product, but if a cat has been persistently scratching at a certain area, skin damage and an open sore may occur. However, hypersensitivity is possible with any topical product and may be related to either the product's active or inactive ingredients. 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 cannot 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.