Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2013-6359

2. Registrant Information.

Registrant Reference Number: PROSAR case #: 1-35273806

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.

18-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

17-OCT-13

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.       PMRA Submission No.       EPA Registration No. 2596-167

Product Name: Ultraguard Flea/Tick Prevention for Dogs/Puppies 15-30 lbs.

  • Active Ingredient(s)
    • ETOFENPROX
      • Guarantee/concentration 55 %
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration 1 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 10 %

7. b) Type of formulation.

Liquid

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).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

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

Unknown

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

25

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
  • Nervous and Muscular Systems
    • Symptom - Depression
  • General
    • Symptom - Death
    • Symptom - Hemorrhage

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

1-35273806 -The reporter, a pet owner, indicated that his dog was exposed to a spot-on product containing the active ingredients etofenprox, n-octyl bicycloheptene dicarboximide and piperonyl butoxide. The reporter applied the product to his 1-year-old, 25 pound, male neutered mixed breed dog one day prior to initial contact with the registrant in the morning and that evening, when the reporter got home from work, he noted that his dog was drowsy. The next morning the dog was found dead. The body was submitted for necropsy to the (name) Veterinary Diagnostic Laboratory. Necropsy revealed a large amount of unclotted blood (estimated to be about 1 liter) in the thoracic cavity. The pathologist indicated that the cause of death was almost certainly intrathoracic hemorrhage. Which per the pathologist may have been secondary to thymic regression leading to either spontaneous bleeding or bleeding secondary to minor trauma and/or spontaneous bleeding secondary to anticoagulant rodenticide ingestion. The pathologist indicated that the fact that the blood was unclotted was supportive of an anticoagulant rodenticide ingestion. Initial brain cholinesterase testing showed 80% suppression of cholinesterase activities which per the pathology laboratory was indicative of poisoning with either an organophosphate or a carbamate. On follow-up call, to the (name) pathology laboratory, the pathologist (Dr. name) indicated that the two findings were unrelated to each other and they planned on re-running the cholinesterase test while using a control to check for lab error. The results of this repeated cholinesterase test are not yet available. During the follow-up call the pathologist also indicated that pyrethroid hair testing did confirm an exposure to etofenprox. Which per the pathologist provided confirmation that the dog had been exposed to etofenprox but did not confirm that the dogs symptoms or its death were secondary to exposure to the etofenprox. No further information is available.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Status update: 1-35273806 - A Second brain cholinesterase analysis using a fresh internal normal was run and results were 33% of normal. Exposure to a cholinesterase-inhibiting compound can be determined if the cholinesterase activity in brain tissues is less than 25% of normal. Therefore, since the results of the second cholinesterase test were greater than 25% of normal there is no evidence that this dog was exposed to a cholinesterase inhibiting compound.