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: 2009-5428

2. Registrant Information.

Registrant Reference Number: Prosar 1-20612055

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.

03-NOV-09

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

01-NOV-09

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/Tick Drops for Dogs/Puppies 31-60 lbs

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

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-151

Product Name: UltraGuard Flea/Tick Drops for Dogs/Puppies 16-30 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 appropriate sized products were applied to 2 dogs on 10/30/2009 or 10/31/2009.

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

Beagle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.46

7. Weight (provide a range if necessary )

17

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Bloody diarrhea
    • Symptom - Vomiting
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Shaking
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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

1-20612055: A reporter (dog owner) called on 11/03/2009 to report the exposure of 2 dogs to a flea and tick product containing the active ingredient Phenothrin. According to the reporter, the appropriate sized product was applied to both dogs on 10/30/2009 or 10/31/2009. On 11/01/2009, Dog #1 (1st Subform III) developed bloody diarrhea, vomiting, anorexia, and shaking. Dog #1 was evaluated by a veterinarian on 11/01/2009. A parvo virus test was negative, and the dog was discharged with activated charcoal. He died at home on 11/01/2009. Dog #1 had been vaccinated but it was unclear which vaccines he had received. Dog #2 (2nd Subform III) developed bloody vomit, diarrhea, and anorexia on 11/01/2009. Dog #2 had not been vaccinated. At the time of the report, Dog #2 had not been evaluated by a veterinarian. The reporter was advised that the signs described are not expected with product use. Occasionally animals may develop dermal irritation, and if the product is ingested via grooming, transient minor gastrointestinal signs like salivation, nausea, or vomiting may be seen. Rarely, an animal may have a sensitivity to the active ingredient and may develop ataxia, tremors, and seizures. A recommendation was made to have Dog #2 evaluated by a veterinarian to determine the cause for his signs. Several attempts at follow up were unsuccessful. No further information was obtained.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Rottweiler

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.83

7. Weight (provide a range if necessary )

45

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Bloody vomit
    • Symptom - Anorexia
    • Symptom - Diarrhea

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

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

1-20612055: A reporter (dog owner) called on 11/03/2009 to report the exposure of 2 dogs to a flea and tick product containing the active ingredient Phenothrin. According to the reporter, the appropriate sized product was applied to both dogs on 10/30/2009 or 10/31/2009. On 11/01/2009, Dog #1 (1st Subform III) developed bloody diarrhea, vomiting, anorexia, and shaking. Dog #1 was evaluated by a veterinarian on 11/01/2009. A parvo virus test was negative, and the dog was discharged with activated charcoal. He died at home on 11/01/2009. Dog #1 had been vaccinated but it was unclear which vaccines he had received. Dog #2 (2nd Subform III) developed bloody vomit, diarrhea, and anorexia on 11/01/2009. Dog #2 had not been vaccinated. At the time of the report, Dog #2 had not been evaluated by a veterinarian. The reporter was advised that the signs described are not expected with product use. Occasionally animals may develop dermal irritation, and if the product is ingested via grooming, transient minor gastrointestinal signs like salivation, nausea, or vomiting may be seen. Rarely, an animal may have a sensitivity to the active ingredient and may develop ataxia, tremors, and seizures. A recommendation was made to have Dog #2 evaluated by a veterinarian to determine the cause for his signs. Several attempts at follow up were unsuccessful. No further information was obtained.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here