Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4155

2. Registrant Information.

Registrant Reference Number: 2023-CA-000189

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.

02-JUN-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

21-MAY-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. 31724      PMRA Submission No.       EPA Registration No.

Product Name: Hartz UltraGuard Rid Flea Dog Shampoo Citrus Scent Shampoo

• Active Ingredient(s)
  • D-PHENOTHRIN

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PMRA Registration No. 30733      PMRA Submission No.       EPA Registration No.

Product Name: Hartz UltraGuard Flea and Tick Drops for Dogs 6 - 14 kg

• 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?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Boston Terrier/American Bulldog crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

11.3

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Skin
  • Symptom - Burns (superficial)
  • Symptom - Erythema
  • Symptom - Other
  • Specify - Application site hair changes (unspecified)

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 18-May-2023, a 10 year old, 11.3 kilogram, neutered, female, Boston Terrier/American Bulldog crossbred dog, in unknown condition, with no known concomitant medical condition, was bathed with an unknown amount of Hartz UltraGuard Rid Flea Dog Shampoo Citrus Scent (Phenothrin (Sumithrin)) via the topical route by the animal owner, then bathed with an unknown amount of unknown of Hartz GROOMERS BEST Soothing Oatmeal Shampoo for Dogs (NA) via the topical route by the animal owner. On 19-May-2023 the dog was also administered 1 tube of Hartz UltraGuard Flea and Tick Drops for Dogs 6 - 14 kg (Phenothrin (Sumithrin)) via the topical route by the animal owner. This was an extra label use due two pesticide products used at once (pesticide shampoo and spot-on) (treatment program not respected). On 21-May-2023, the dog developed application site erythema, application site burns, and application site hair changes (unspecified). On approximately 02-Jun-2023, the dog was bathed with liquid degreasing dish soap and then also bathed using an unspecified oatmeal shampoo. On 12-Jun-2023, the dog was evaluated by a veterinarian and prescribed a combination trimeprazine tartrate and prednisolone medication. The dog was also prescribed an unspecified flea and tick topical product and was vaccinated with an unspecified distemper, parvovirus, and Rabies vaccine. The dog had previously been administered Hartz UltraGuard Flea and Tick Drops for Dogs 6 - 14 kg (Phenothrin (Sumithrin)) via the topical route by the animal owner on 17-Apr-2023 without issue. 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: Dermal irritation is possible following use of any topical product and may be related to either the active ingredients or the carrier in the products. Burns are not anticipated though some animals may be more sensitive to certain ingredients than others. It is difficult to predict which individual animals may develop this type of reaction to a product. Persistent scratching may also lead to abrasion and trauma to the skin. 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.