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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-1581

2. Registrant Information.

Registrant Reference Number: Prosar case 1-15901976

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.

15-MAR-08

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

15-MAR-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. 2596-22

Product Name: Advanced Care 2 in 1 Rid Flea Dog Shampoo

  • Active Ingredient(s)
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .135 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .08 %
    • PYRETHRINS
      • Guarantee/concentration .04 %

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 applied the product on 3/15/08 to a litter of 3 puppies (14 weeks old). Two puppies experienced symptoms and 1 died. The 3rd puppy never developed any symptoms. The reporter had used the product once previously on the same puppies with no symptoms or complications.

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 and Poodle mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.26

7. Weight (provide a range if necessary )

1

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 <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Respiratory System
    • Symptom - Respiratory distress
  • Nervous and Muscular Systems
    • Symptom - Collapse
  • Respiratory System
    • Symptom - Sneezing
  • Eye
    • Symptom - Other
    • Specify - Blood coming out of her eye
  • General
    • Symptom - Death
  • Respiratory System
    • Symptom - Coughing up blood
    • Specify - hemoptysis

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

1-15901976: The reporter called on 3/15/08 to report that 2 of their 14 week old Chihuahua-Poodle mix puppies developed symptoms after being bathed with a product that contains the active ingredients Pyrethrins, Piperonyl Butoxide, and N-Octyl Bicyloheptene Dicarboximide. The reporter stated they had been bathed 2 hours prior to the call. At the time of the call the female puppy was in respiratory distress and had collapsed, while the male puppy was vomiting and also seemed in respiratory distress. The reporter's significant other was in the process of treating the male puppy with a nebulizer and the puppy's breathing was improving. The reporter speculated the puppies had ingested some bath water. Treatment advice was sought and given, which included the recommendation to have them immediately evaluated by a veterinarian. Approximately 20 minutes after the initial call, the reporter called back. She stated that the male puppy had vomited clear fluid and was now OK. She further stated that the female puppy had experienced some hemoptysis, sneezed, blood had came out of her eye, and then she had died. At the time of the second call, the reporter denied the puppies had swallowed or licked any of the product. Sympathy at the caller's loss was expressed and a company sponsored necropsy was discussed. The caller declined the necropsy. The 3rd puppy never developed any symptoms. The reporter had used the product once previously on the same puppies with no symptoms or complications.


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

Chihuahua and Poodle mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.26

7. Weight (provide a range if necessary )

2.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Respiratory System
    • Symptom - Respiratory distress
  • Gastrointestinal System
    • Symptom - Vomiting

12. How long did the symptoms last?

<=30 min / <=30 min

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

1-15901976: The reporter called on 3/15/08 to report that 2 of their 14 week old Chihuahua-Poodle mix puppies developed symptoms after being bathed with a product that contains the active ingredients Pyrethrins, Piperonyl Butoxide, and N-Octyl Bicyloheptene Dicarboximide. The reporter stated they had been bathed 2 hours prior to the call. At the time of the call the female puppy was in respiratory distress and had collapsed, while the male puppy was vomiting and also seemed in respiratory distress. The reporter's significant other was in the process of treating the male puppy with a nebulizer and the puppy's breathing was improving. The reporter speculated the puppies had ingested some bath water. Treatment advice was sought and given, which included the recommendation to have them immediately evaluated by a veterinarian. Approximately 20 minutes after the initial call, the reporter called back. She stated that the male puppy had vomited clear fluid and was now OK. She further stated that the female puppy had experienced some hemoptysis, sneezed, blood had came out of her eye, and then she had died. At the time of the second call, the reporter denied the puppies had swallowed or licked any of the product. Sympathy at the caller's loss was expressed and a company sponsored necropsy was discussed. The caller declined the necropsy. The 3rd puppy never developed any symptoms. The reporter had used the product once previously on the same puppies with no symptoms or complications.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here