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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3186

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16178829

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-MAY-08

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

Unknown

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. 26490      PMRA Submission No.       EPA Registration No.

Product Name: Control Pet Care System One Spot for Dogs/Puppies Over 14 kg

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PERMETHRIN

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 had applied the product to her 2 dogs 4 days prior to the call.

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

Rottweiler

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

160

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Skin
    • Symptom - Hair loss
    • Symptom - Irritated skin
    • Symptom - Bleeding

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

1-16178829: The reporter called on 5/22/08 to report she had applied a topical flea and tick product containing the active ingredients Permethrin and Methoprene to her two dogs 4 days previously. According to the owner, one dog (1st subform III) had developed hair loss and dermal irritation at the application site while the second dog (2nd subform III) had been vomiting for the last few days. The safety profile of the product was discussed. This included the possibility of GI upset if some of the product had been ingested, and dermal irritation as an idiosyncratic reaction. A recommendation was made to bathe the 1st dog to remove the product, and to monitor hydration for the 2nd dog, giving fluids as needed to replace those lost. It was further recommended to seek veterinary care if symptoms persisted or worsened. It was suggested that an alternative product be used in the future for the 1st dog. A follow-up call was placed on 5/23 and was returned the same day. The reporter revealed the 2nd dog had stopped vomiting, but the 1st dog¿s skin irritation had worsened to the point of bleeding. The reporter stated she had not taken the pet to a veterinarian as she could not afford care. She inquired about and was given information regarding the kind of care she could accomplish at home, including irrigating the area and applying an antibiotic ointment. She was again encouraged to seek veterinary care if the symptoms worsened.


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

Rottweiler

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

140

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

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

1-16178829: The reporter called on 5/22/08 to report she had applied a topical flea and tick product containing the active ingredients Permethrin and Methoprene to her two dogs 4 days previously. According to the owner, one dog (1st subform III) had developed hair loss and dermal irritation at the application site while the second dog (2nd subform III) had been vomiting for the last few days. The safety profile of the product was discussed. This included the possibility of GI upset if some of the product had been ingested, and dermal irritation as an idiosyncratic reaction. A recommendation was made to bathe the 1st dog to remove the product, and to monitor hydration for the 2nd dog, giving fluids as needed to replace those lost. It was further recommended to seek veterinary care if symptoms persisted or worsened. It was suggested that an alternative product be used in the future for the 1st dog. A follow-up call was placed on 5/23 and was returned the same day. The reporter revealed the 2nd dog had stopped vomiting, but the 1st dog¿s skin irritation had worsened to the point of bleeding. The reporter stated she had not taken the pet to a veterinarian as she could not afford care. She inquired about and was given information regarding the kind of care she could accomplish at home, including irrigating the area and applying an antibiotic ointment. She was again encouraged to seek veterinary care if the symptoms worsened.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here