Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-1697

2. Registrant Information.

Registrant Reference Number: 2023-CA-000042

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.

23-FEB-23

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

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. 31724      PMRA Submission No.       EPA Registration No.

Product Name: Hartz UltraGuard Rid Flea Oatmeal Dog Shampoo 18 oz Shampoo

• 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).

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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

2.7

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Skin
  • Symptom - Dry skin
  • Specify - Skin slough
  • Symptom - Red skin
  • Symptom - Irritated skin
  • Symptom - Lesion
  • Specify - Skin scab

12. How long did the symptoms last?

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

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

Fully Recovered / Complètement rétabli

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 an unknown date in approximately Jan-2023, a 9 year old, approximately 2.7 kilogram, neutered, male, Yorkshire Terrier dog, in unknown condition, with no known concomitant medical conditions, was administered 1 application of Hartz UltraGuard Rid Flea Oatmeal Dog Shampoo 18 oz (Phenothrin (Sumithrin)) via the topical route by the animal owner. Approximately six hours post product administration, the dog developed red, irritated skin that started to scab and fall off. The dog was evaluated by a veterinarian on an unspecified date and prescribed a medicated ointment (unspecified active ingredients) to be applied topically to the wounds and meloxicam to be given orally by the animal owner, as directed by the veterinarian. The clinical signs resolved approximately three days later. On approximately 09-Feb-2023, the dog was again administered 1 application of Hartz UltraGuard Rid Flea Oatmeal Dog Shampoo 18 oz (Phenothrin (Sumithrin)) via the topical route by the animal owner. The same clinical signs developed approximately six hours post administration and the dog was administered the same two medications by the animal owner, as directed by the veterinarian. On approximately 13-Feb-2023, the clinical signs resolved and the dog recovered. The animal owner had a difficult time providing specific dates in this case. No further information is 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: The active ingredient is present in very low concentration in this product and has a wide margin of safety in dogs. While the signs reported in this case are not anticipated following labeled use of the product, an animal may have an individual sensitivity to any one of the product ingredients leading to a reaction. Such reactions are difficult to predict. 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.