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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3634

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16052517

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.

22-APR-08

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

20-APR-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.

Product Name: Control Pet Care System Once A Month Flea and Tick Treatment for Dogs

  • 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).

The reporter applied the product to her two dogs on 4/20/08.

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

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

5

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

  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy

12. How long did the symptoms last?

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

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

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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

1-16052517: The reporter called on 4/22/08 to report her two dogs had developed symptoms after she had applied a topical flea and tick product which contained the active ingredient Phenothrin. The reporter had applied the product the evening of 4/20/08. Her male dog (1st subform) had developed anorexia and lethargy the next day (4/21), so the reporter had bathed the dog in the morning and taken him to veterinarian. At the time of the call, the dog was back at home and had improved. The reporter did not know what treatments had been done to him at the veterinary clinic. The second dog (female, 2nd subform), had immediately become agitated after the product had been applied on 4/20. She shook/had tremors and vocalized all night and the next day (4/21) the reporter bathed her. The dog had then been lethargic, anorexic, and stiff/sore all day, so the reporter took her to the veterinarian the evening of 4/22 for unknown treatments. At the time of the 4/22 call, the female dog was still anorexic. The safety profile of the product was discussed with the reporter, as well as prognosis and reimbursement information. A follow-up call on 4/23 revealed the female dog was doing much better and had resumed eating.


To be determined by Registrant

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

Moderate

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

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

3.2

lbs

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 / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Agitation
  • General
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Shaking
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Stiffness

12. How long did the symptoms last?

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

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

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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

1-16052517: 1-16052517: The reporter called on 4/22/08 to report her two dogs had developed symptoms after she had applied a topical flea and tick product which contained the active ingredient Phenothrin. The reporter had applied the product the evening of 4/20/08. Her male dog (1st subform) had developed anorexia and lethargy the next day (4/21), so the reporter had bathed the dog in the morning and taken him to veterinarian. At the time of the call, the dog was back at home and had improved. The reporter did not know what treatments had been done to him at the veterinary clinic. The second dog (female, 2nd subform), had immediately become agitated after the product had been applied on 4/20. She shook/had tremors and vocalized all night and the next day (4/21) the reporter bathed her. The dog had then been lethargic, anorexic, and stiff/sore all day, so the reporter took her to the veterinarian the evening of 4/22 for unknown treatments. At the time of the 4/22 call, the female dog was still anorexic. The safety profile of the product was discussed with the reporter, as well as prognosis and reimbursement information. A follow-up call on 4/23 revealed the female dog was doing much better and had resumed eating.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here