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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3627

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16036175

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.

17-APR-08

5. Location of incident.

Country: UNITED STATES

Prov / State: OKLAHOMA

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. 2596-140

Product Name: UltraGuard Plus Flea and Tick Spray for Dogs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .07 %
    • TETRACHLORVINPHOS
      • Guarantee/concentration 1.08 %

7. b) Type of formulation.

Other (specify)

Spray

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 used the product several times, 1-2 weeks apart. The reporter used the product on a nursing bitch and her puppies, contrary to label directions. Some of the reporter's dogs developed symptoms after the second use.

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

Blue Heeler

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 )

Unknown

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 - Gagging
  • General
    • Symptom - Parvovirus infection
    • Specify - Diagnosed with Parvovirus

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

1-16036175: The reporter called on 4/17/08 to report several of his dogs were vomiting after he had treated them with a topical flea and tick product containing the active ingredients Tetrachlorvinphos and Methoprene. He had used the product several times, 1-2 weeks apart. Vomiting symptoms developed after the second use of the product. First aid information was given, which included recommendations to bathe the dogs for decontamination, replace fluids as needed, and consult a veterinarian if the symptoms persisted or worsened. The reporter called back later that same day and revealed that the product had been used on a nursing bitch and her puppies (contrary to label directions). The mother was asymptomatic. One of the puppies (1st sub form III) initially gagged and then was fine. One puppy had died on 4/16/08 after experiencing bloody diarrhea and vomiting. The 3rd puppy had been vomiting since the evening of 4/16/08 and a few hours ago had developed bloody diarrhea. The reporter suspected Parvovirus and had given a vaccination for the same earlier on 4/17/08. The reporter was wondering how long symptoms might last after the dogs were bathed. The timeframe for this was discussed and a recommendation was made to bring the dogs into a veterinarian for a full examination, especially if the symptoms did not resolve a few hours after the bath. Several attempts were made at follow-up. Contact with the reporter was re-established on 4/21/08, and revealed the dogs were taken to a veterinarian who diagnosed Parvovirus, the 3rd puppy had died on 4/19/08, and the remaining dogs were under treatment and were OK.


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

Blue Heeler

4. Number of animals affected

2

5. Sex

Male

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

Unknown

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 - Vomiting
    • Symptom - Bloody diarrhea
  • General
    • 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

1-16036175: The reporter called on 4/17/08 to report several of his dogs were vomiting after he had treated them with a topical flea and tick product containing the active ingredients Tetrachlorvinphos and Methoprene. He had used the product several times, 1-2 weeks apart. Vomiting symptoms developed after the second use of the product. First aid information was given, which included recommendations to bathe the dogs for decontamination, replace fluids as needed, and consult a veterinarian if the symptoms persisted or worsened. The reporter called back later that same day and revealed that the product had been used on a nursing bitch and her puppies (contrary to label directions). The mother was asymptomatic. One of the puppies (1st sub form III) initially gagged and then was fine. One puppy had died on 4/16/08 after experiencing bloody diarrhea and vomiting. The 3rd puppy had been vomiting since the evening of 4/16/08 and a few hours ago had developed bloody diarrhea. The reporter suspected Parvovirus and had given a vaccination for the same earlier on 4/17/08. The reporter was wondering how long symptoms might last after the dogs were bathed. The timeframe for this was discussed and a recommendation was made to bring the dogs into a veterinarian for a full examination, especially if the symptoms did not resolve a few hours after the bath. Several attempts were made at follow-up. Contact with the reporter was re-established on 4/21/08, and revealed the dogs were taken to a veterinarian who diagnosed Parvovirus, the 3rd puppy had died on 4/19/08, and the remaining dogs were under treatment and were OK.


To be determined by Registrant

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

Death

19. Provide supplemental information here