Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-2678

2. Registrant Information.

Registrant Reference Number: 2020-CA-000401 and 2020-CA-000402 (combined)

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-NOV-20

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

07-OCT-20

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. 30733      PMRA Submission No.       EPA Registration No.

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

• Active Ingredient(s)
  • D-PHENOTHRIN
    • Guarantee/concentration 85.7 %

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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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Terrier (Unspecified)/Crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

12.7

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

• Nervous and Muscular Systems
  • Symptom - Agitation

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Vocalizing

• Nervous and Muscular Systems
  • Symptom - Seizure

• Skin
  • Symptom - Lesion
  • Symptom - Hair loss
  • Symptom - Rash

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 07-Oct-2020, a 5 year old, 12.7 kilogram, neutered, male, Terrier (Unspecified)/Crossbred dog, in unknown condition, with no known concomitant medical condition, was 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. Five minutes post application, the dog developed agitation, application site pruritus, rubbing on the floor, and whining. The dog was bathed using an unknown amount of unspecified shampoo and conditioner for dogs by the animal owner. The clinical signs continued and the dog was then bathed using an unknown amount of unspecified oatmeal shampoo. There was no improvement with the clinical signs. Approximately 6 hours later, the dog exhibited multiple seizures. On 08-Oct-2020, the dog was brought to the emergency veterinary facility for evaluation. Unspecified blood work was performed and the results were within normal limits. Upon physical exam, the veterinarian discovered sores and hair loss at unspecified sites due to scratching. A rash on the chest, abdomen, base of tail and back was also noted. The veterinarian reportedly stated that the dog seemed to be suffering from neurological damage due to product use. Gabapentin was prescribed for three times daily for 7 days. On 09-Oct-2020, the dog was brought back to the emergency veterinary facility and re-evaluated due to continued seizures. The veterinarian referred the dog to a neurologist, but the animal owner declined referral due to distance and financial constraints. On 13-Oct-2020, the dog was re-evaluated by a veterinarian and prescribed additional gabapentin. The dog continued to have small, intermittent seizures. On 21-Oct-2020, the seizures resolved but the other clinical signs continued. Gabapentin was discontinued. On 13-Nov-2020 the animal owner administered an unknown amount of unspecified hydrocortisone cream to the rash on the dog's abdomen. As of 19-Nov-2020 the prior areas of alopecia had hair growing back and the dog is still seen rubbing its back occasionally. The dog was previously treated with the same Hartz spot-on product several years prior. On an unspecified date following that application, the dog exhibited mild signs of pruritus and agitation. 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: Seizures are not expected following topical use of this product however, some animals may be more sensitive to pyrethroid insecticides than others. Paresthesia, an intense tingling sensation on the skin, may occur which can manifest as agitation, trembling, shaking, hiding, and other behavior changes in dogs. The sensation of fleas dying on the pet may cause similar signs. Mild GI upset may occur if the product was ingested while wet at the application site. Other causes including idiopathic epilepsy and misinterpretation of signs related to paresthesia should be considered. 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.