Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4188

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16373227

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.

08-JUL-08

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

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.       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 %

---

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

Product Name: Advanced Care 3 in 1 Once a Month Flea/Tick Drops for Dogs 31-60 lbs

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

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-22

Product Name: UltraGuard Rid Flea Dog Shampoo Refreshing Fresh Citrus

• Active Ingredient(s)
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration .149 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration .089 %
  • PYRETHRINS
    • Guarantee/concentration .45 %

---

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 reporter washed his 2 dogs with the shampoo and then applied the appropriate weight class of topical flea and tick drops to the dogs on the same day. Consequently, each dog had been exposed to 2 products on the same day - Pyrethrin based shampoo and Phenothrin based topical flea and tick drops. Once a flea and tick shampoo has been used, it is recommended to wait 5 days before applying any sort of flea and tick drops.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Mixed

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 )

9

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

• General
  • Symptom - Abnormal behaviour
  • Specify - Not acting normally
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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

1-16373227: The reporter called on 7/8/08 to report the death of one dog and the illness of another dog after the application of several flea and tick products. According to the reporter, he had washed his 2 dogs with a flea and tick shampoo containing the active ingredients Pyrethrins, Piperonyl Butoxide, and N-Octyl Bicycloheptene Dicarboximide. He had then applied the appropriate weight class of a Phenothrin based topical flea and tick drops to each of his dogs on the same day. Consequently, each dog had been exposed to 2 products on the same day. The reporter stated that the smaller dog (1st subform III) had not been himself since the products had been applied and that he had passed away within 4 days. The 2nd dog had also not been herself (2nd subform III) since the application of the products. By the time of the call, the reporter had noticed hair loss along her back, and she had had several seizures. It was discussed that once a flea and tick shampoo has been used, it is recommended to wait 5 days before applying any sort of flea and tick drops. A recommendation was made to take the dog to a veterinarian for evaluation. A follow-up call revealed that the dog had been bathed and had improved by the next day. The dog had not been taken to a veterinarian.

---

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

German Shephard

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

50

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

• Nervous and Muscular Systems
  • Symptom - Seizure

• Skin
  • Symptom - Hair loss

• General
  • Symptom - Abnormal behaviour
  • Specify - Not acting normally/right

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

1-16373227: The reporter called on 7/8/08 to report the death of one dog and the illness of another dog after the application of several flea and tick products. According to the reporter, he had washed his 2 dogs with a flea and tick shampoo containing the active ingredients Pyrethrins, Piperonyl Butoxide, and N-Octyl Bicycloheptene Dicarboximide. He had then applied the appropriate weight class of a Phenothrin based topical flea and tick drops to each of his dogs on the same day. Consequently, each dog had been exposed to 2 products on the same day. The reporter stated that the smaller dog (1st subform III) had not been himself since the products had been applied and that he had passed away within 4 days. The 2nd dog had also not been herself (2nd subform III) since the application of the products. By the time of the call, the reporter had noticed hair loss along her back, and she had had several seizures. It was discussed that once a flea and tick shampoo has been used, it is recommended to wait 5 days before applying any sort of flea and tick drops. A recommendation was made to take the dog to a veterinarian for evaluation. A follow-up call revealed that the dog had been bathed and had improved by the next day. The dog had not been taken to a veterinarian.

---

To be determined by Registrant

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

Moderate

19. Provide supplemental information here