Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2292

2. Registrant Information.

Registrant Reference Number: 2019-CA-000156

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.

27-OCT-19

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

25-OCT-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. 31724      PMRA Submission No.       EPA Registration No.

Product Name: Hartz UltraGuard Rid Flea Dog Shampoo Citrus Scent

• 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

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Lethargy

• Respiratory System
  • Symptom - Tachypnea

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 25-Oct-2019, an 11 year old, 5 pound, intact, male, Shih Tzu dog, in unknown condition, with concomitant medical conditions of a single seizure 18 months prior and ticks, was administered for the first time, an unknown amount of Hartz UltraGuard Rid Flea Dog Shampoo Citrus Scent (Phenothrin) via the topical route by the animal owner. This was an extra label use as the product was not left on the dog for five minutes prior to rinsing. Approximately eight hours post application, the dog fell off the bed while sleeping, and then exhibited ataxia, anorexia, and fast, shallow breathing. The symptoms worsened and on 27-Oct-2019, the dog was brought to an emergency facility, where he was evaluated by a veterinarian and administered unspecified fluid therapy. The dog was diagnosed with a unilateral ear infection and was prescribed Marbofloxacin-Clotrimazole-Dexamethasone Acetate ear drops. The veterinarian did not comment about suspecting product involvement when informed that the dog had been bathed with the product. The clinical signs persisted at the time of the call. Encouragement of food and water intake and bathing with liquid dish soap was discussed. Further veterinary evaluation was recommended if the symptoms persisted or worsened. No further information was received in this case.

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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 low concentration in this product and has a wide margin of safety in dogs. The signs reported are not anticipated following use. The dog was diagnosed with a unilateral ear infection which is a more likely cause of being off-balance. The dog also has a history of prior seizures making central nervous system disease a potential cause as well. Anorexia and irregular breathing may be secondary signs related to pain either due to the ear infection or trauma after falling. 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.