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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2264

2. Registrant Information.

Registrant Reference Number: 2019-CA-000057

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.

16-JUL-19

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

11-JUL-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. 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

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

Crossbred Canine

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

8

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Renal System
    • Symptom - Inappropriate urination
  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Anorexia

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 10-Jul-2019, a 4 year old, approximately 8 pound, intact, male, Crossbred Canine dog, in unknown condition, with concomitant medical conditions of fleas and pruritus, was administered 1 tube of Hartz UltraGuard Flea and Tick Drops for Dogs 6 - 14 kg (Phenothrin) via the topical route by the animal owner. This was an extra label use as it was an overdose of product. On 11-Jul-2019, the dog developed lethargy. On 12-Jul-2019, the dog developed inappropriate urination. On 13-Jul-2019, the dog developed diarrhea and anorexia. The dog was not evaluated by a veterinarian, no treatments were performed, and the clinical signs continued. Bathing the dog with liquid dish soap and seeking veterinary evaluation was recommended if the clinical signs persisted or worsened. 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: Pyrethroid insecticides, including phenothrin, may cause a paresthesia sensation on the skin which can be distressing for some animals. In dogs, signs including lethargy, agitation, trembling, and other behavior changes may occur. It is possible the dog developed inappropriate urination if it was stressed by this sensation. Similar behavior changes may occur secondary to the feeling of fleas dying on the pet as well. GI upset including vomiting, diarrhea, and anorexia may occur if the product is ingested while still wet at the application site. Anorexia and diarrhea may be related to stress as well. 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.