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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2273

2. Registrant Information.

Registrant Reference Number: 2019-CA-000085

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-AUG-19

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

17-AUG-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)

PMRA Registration No. 25381      PMRA Submission No.       EPA Registration No.

Product Name: Hartz UltraGuard Plus Flea and Tick Collar for Cat and Kittens

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

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 )

6

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus
    • Symptom - Hair loss
    • Symptom - Lesion

12. How long did the symptoms last?

Unknown / Inconnu

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

No

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 12-Aug-2019, a 6 year old, approximately 10 pound, neutered, male, Domestic Shorthair cat, in unknown condition, with concomitant medical condition of fleas, was administered 1 collar of Hartz UltraGuard Plus Flea and Tick Collar for Cat and Kittens (Tetrachlorvinphos / S Methoprene) via the topical route by the animal owner. On 17-Aug-2019, the cat developed application site pruritus, application site hair loss, and application site lesions (ulcerations) on the sides on the neck that were approximately five to eight centimeters long. On 18-Aug-2019, the collar was removed and Emu oil was applied to the application site by the animal owner. On 19-Aug-2019, the clinical signs improved but continued. The cat had not been evaluated by a veterinarian and no treatment had been performed. Veterinary evaluation was recommended due to the presence of skin lesions. No further information was received in this case.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Assessment: Skin lesions or ulcerations are not anticipated simply from application of the product, but if the cat has been persistently scratching at a certain area, skin damage and an open sore may occur. Hypersensitivity can occur with any topical product and may be related to either the product's active or inactive ingredients. Persistent scratching due to fleas may have also contributed to signs. 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.