Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-1436

2. Registrant Information.

Registrant Reference Number: PROSAR 1-21876449

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.

10-MAR-10

5. Location of incident.

Country: UNITED STATES

Prov / State: LOUISIANA

6. Date incident was first observed.

06-MAR-10

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-125

Product Name: UltraGuard Flea/Tick Spray for Dogs 16 fl oz

• Active Ingredient(s)
  • TETRACHLORVINPHOS
    • Guarantee/concentration 1.08 %

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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 to Dog #1 on 03/04 or 03/05/2010. The product was applied to Dog #2 on 03/09/2010.

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

Unknown breed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

25

lbs

8. Route(s) of exposure

Skin

Oral

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 - Vomiting
  • Symptom - Diarrhea

• General
  • Symptom - Lethargy
  • 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

1-21876449: A reporter (dog owner) called on 03/10/2010 to report the exposure of her 2 dogs to a flea and tick spray containing the active ingredient Tetrachlorvinphos. According to the reporter, the product was applied to Dog #1 (1st Subform III) on 03/04 or 03/05/2010. The dog was seen licking the product off itself on 03/05/2010. On 03/06/2010, Dog #1 developed vomiting, diarrhea, and lethargy. The reporter treated the dog with Kao-Pectate and the signs persisted. The reporter called her veterinarian who suspected Parvovirus as the reason for the signs. Dog #1 was not seen by a veterinarian and died on 03/09/2010. Dog #2 (2nd Subform III) was treated with the product on 03/09/2010. By that evening, the dog had developed vomiting and diarrhea. The reporter was advised that the product has a wide range of safety and ingestion of small amounts from the hair coat are not expected to result in the signs described. A recommendation was made to have the dog evaluated by a veterinarian. The company's cholinesterase testing program was mentioned. On follow up on 03/11/2010, the reporter stated that Dog #2 was not evaluated by a veterinarian, and that his signs resolved within 1.5 days. The reporter called back spontaneously on 03/12/2010 to report that Dog #2 was having signs again and that she planned to take him to the veterinarian. The reporter was advised that veterinary evaluation is recommended, and the company's reimbursement policy was discussed. On follow up on 03/17/2010, the reporter stated that Dog #2 was taken back to the veterinarian and treated with IV fluids, medications for gastrointestinal upset, and antibiotics for an ear infection. No further information was obtained.

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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

Boston Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

4.5

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 - Vomiting
  • Symptom - Diarrhea

12. How long did the symptoms last?

Unknown / Inconnu

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

1-21876449: A reporter (dog owner) called on 03/10/2010 to report the exposure of her 2 dogs to a flea and tick spray containing the active ingredient Tetrachlorvinphos. According to the reporter, the product was applied to Dog #1 (1st Subform III) on 03/04 or 03/05/2010. The dog was seen licking the product off itself on 03/05/2010. On 03/06/2010, Dog #1 developed vomiting, diarrhea, and lethargy. The reporter treated the dog with Kao-Pectate and the signs persisted. The reporter called her veterinarian who suspected Parvovirus as the reason for the signs. Dog #1 was not seen by a veterinarian and died on 03/09/2010. Dog #2 (2nd Subform III) was treated with the product on 03/09/2010. By that evening, the dog had developed vomiting and diarrhea. The reporter was advised that the product has a wide range of safety and ingestion of small amounts from the hair coat are not expected to result in the signs described. A recommendation was made to have the dog evaluated by a veterinarian. The company's cholinesterase testing program was mentioned. On follow up on 03/11/2010, the reporter stated that Dog #2 was not evaluated by a veterinarian, and that his signs resolved within 1.5 days. The reporter called back spontaneously on 03/12/2010 to report that Dog #2 was having signs again and that she planned to take him to the veterinarian. The reporter was advised that veterinary evaluation is recommended, and the company's reimbursement policy was discussed. On follow up on 03/17/2010, the reporter stated that Dog #2 was taken back to the veterinarian and treated with IV fluids, medications for gastrointestinal upset, and antibiotics for an ear infection. No further information was obtained.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here