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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2318

2. Registrant Information.

Registrant Reference Number: 2020-CA-000138

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.

22-MAY-20

5. Location of incident.

Country: CANADA

Prov / State: MANITOBA

6. Date incident was first observed.

02-FEB-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)

PMRA Registration No. 31724      PMRA Submission No.       EPA Registration No.

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

  • 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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Bichon Frise/Shih Tzu crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

15

7. Weight (provide a range if necessary )

20

lbs

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 <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Restlessness
    • Symptom - Muscle twitching
  • General
    • Symptom - Lethargy
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Died

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 02-Feb-2020, a 15 year old, approximately 20 pound, unknown, male, Bichon Frise/Shih Tzu crossbred dog, in unknown condition, with no known concomitant medical condition, 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 1 hour post administration, the dog developed restlessness, muscle twitching and lethargy. The dog was brought to an emergency veterinary facility, but died in the parking lot. The dog had not been evaluated by a veterinarian, no treatment had been performed and no necropsy had been performed. The dog was cremated on 03-Feb-2020. The animal owner also administered the same product via the topical route, to three other dogs the same day and no clinical signs were reported.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Assessment: The active ingredient in this product is present in low concentration and has a wide margin of safety in dogs. Restlessness, lethargy, or skin twitching behaviors are possible following use if a paresthesia response occurs or may be related to the sensation of fleas dying on the pet (if present). Systemic neurological signs and death are not expected. Other causes should be considered in this case including an unknown toxin exposure, unknown trauma, underlying neoplasia, or metabolic disease. 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.