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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2288

2. Registrant Information.

Registrant Reference Number: 2019-CA-000136

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.

08-OCT-19

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

08-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)

PMRA Registration No. 30731      PMRA Submission No.       EPA Registration No.

Product Name: Hartz UltraGuard Pro Drops for Dogs Over 28 kg

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • 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

Mixed Breed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

28

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

11. List all symptoms

System

  • General
    • Symptom - Hiding
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
  • General
    • Symptom - Lethargy
    • Symptom - Licking
  • Skin
    • Symptom - Erythema
    • Symptom - Lesion
    • Specify - raw appearance

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 07-Oct-2019, an 8 year old, 61.7 pound, neutered, female, mixed breed dog, in unknown condition, with no known concomitant medical conditions, was administered an unknown amount of unspecified flea and tick spray via the topical route by the animal owner. On 08-Oct-2019, the dog exhibited reluctance to move and had the odor of the product was very strong. The dog was bathed with an unknown amount of unspecified dog shampoo by a groomer. At an unspecified time post bathing, the dog was administered 1 tube of Hartz UltraGuard Pro Drops for Dogs Over 28 kg (Phenothrin/(S)-Methoprene) via the topical route by the animal owner. Approximately two hours post-application, the dog developed hiding, intermittent tremors, lethargy, and excessive licking at the application site. Some of the product ran from the application site down to the dog's inguinal region. Approximately five hours post-application, the area where the product ran onto became erythematous and had a very raw appearance (skin lesion). The pet owner bathed the dog with liquid dish soap daily from 10-Oct-2019 to 13-Oct-2019 and applied vitamin E oil to the red area of skin starting on 10-Oct-2019 with no improvement seen by 13-Oct-2019. Veterinary evaluation was recommended. 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: Paresthesia may occur following topical application of pyrethroid insecticides, including phenothrin. This sensation may be stressful in some animals and can manifest as agitation, trembling, shaking, hiding, and other behavior changes. Skin lesions are not anticipated simply from application of the product, but if the dog has been persistently scratching or licking at a certain area, skin damage and an open sore may occur. Hypersensitivity can occur with any topical product and may be related to either the product's active or inactive ingredients. 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.