Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4234

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16248929

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.

07-JUN-08

5. Location of incident.

Country: UNITED STATES

Prov / State: LOUISIANA

6. Date incident was first observed.

07-JUN-08

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. 2596-151

Product Name: UltraGuard Flea and Tick Drops for Dogs and Puppies 4-15 lbs.

  • Active Ingredient(s)
    • D-PHENOTHRIN
      • Guarantee/concentration 85.7 %

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).

The product was applied on a 10-12 week old puppy on 6/6/08. If the puppy was on the younger side of the range, the product was used against label directions.

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

Female

6. Age (provide a range if necessary )

0.20

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Anorexia
  • General
    • 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

1-16248929: The reporter called on 6/7/08 to report she had applied a topical flea and tick product containing the active ingredient Phenothrin to her 10-12 week old puppy the previous day. According to the owner, the puppy had been fine until the day of the call, when she had developed vomiting and anorexia. The safety profile of the product was discussed, as was the correct age for product use. A recommendation was made to bathe the puppy in a non-insecticidal shampoo and to add Pedialyte to the puppy┐s water to help maintain hydration. It was further recommended that the reporter take the puppy to a veterinarian if the symptoms did not resolve after bathing. A follow-up call on 6/11 revealed the puppy had passed away the evening of 6/8. The reporter had spoken with her veterinarian, but had not taken the puppy in for evaluation. She had been giving Pedialyte plus Similac with iron at home.


To be determined by Registrant

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

Death

19. Provide supplemental information here