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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2294

2. Registrant Information.

Registrant Reference Number: 2019-CA-000168

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-NOV-19

5. Location of incident.

Country: CANADA

Prov / State: NEW BRUNSWICK

6. Date incident was first observed.

06-NOV-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. 31724      PMRA Submission No.       EPA Registration No.

Product Name: Hartz UltraGuard Rid Flea Dog Shampoo Fresh Scent

  • 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

Border Collie

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

50

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Shaking
    • Symptom - Muscle twitching
    • Symptom - Head shaking
    • Symptom - Ataxia
    • Symptom - Paresis
    • Symptom - Other
    • Specify - Eyes rolling back
  • General
    • Symptom - Lethargy
  • Respiratory System
    • Symptom - Coughing
  • General
    • Symptom - Loss of voice
  • Ear
    • Symptom - Other
    • Specify - ear twitching

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 06-Nov-2019, a 1 year old, 50 pound, neutered, female, Border Collie dog, in unknown condition, with no known concomitant medical conditions, was administered an unknown amount of Hartz UltraGuard Rid Flea Dog Shampoo Fresh Scent (Phenothrin) via the topical route by the animal owner. Approximately 20 minutes post application, the dog exhibited shaking (as if cold), generalized twitching, ear twitching, and head shaking. Approximately 45 minutes post application, the dog exhibited ataxia, dragging a back leg, eyes rolling back, and lethargy. An emergency veterinarian was called and consulted via phone. The dog was bathed using an unknown amount of liquid dish soap by the animal owner, as recommended by the veterinarian. Approximately 3 hours post application, the clinical signs resolved. On 07-Nov-2019, the dog exhibited a dry cough and lost her voice (bark). On 08-Nov-2019, the dog's voice (bark) returned and she was administered an unknown amount of coconut oil and an unknown amount of honey by the animal owner. The dog was evaluated by a veterinarian, diagnosed with kennel cough and was prescribed unspecified antibiotics. The dog was improved at the time of the call but the symptoms continued.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Assessment: The initial reported signs of shaking, twitching, and head shaking, and lethargy may have been related to a paresthesia (tingling) response on the skin. Pyrethroid insecticides, including phenothrin, may cause paresthesia which can be distressing to some animals. Altered gait may occur if paresthesia is occuring on the paws, but true ataxia and rear limb paresis are not expected. Signs resolved with bathing only. The latter signs of coughing and loss of bark are not consistent with the toxicological profile of the product but are consistent with kennel cough. 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.