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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3641

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16077601

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.

28-APR-08

5. Location of incident.

Country: UNITED STATES

Prov / State: ALABAMA

6. Date incident was first observed.

15-APR-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. 68688-41-2596

Product Name: Ear Mite Treatment for Dogs

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .5 %
    • PYRETHRINS
      • Guarantee/concentration .05 %

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 instilled the product in the ears of 3 puppies on 4/14/08.

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

Pomeranian

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.33

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
  • Liver
    • Symptom - Hepatic failure
    • Specify - Liver failure/dysfunction - cirrhosis
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

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

1-16077601: The reporter called on 4/28/08 to report she had instilled a topical ear mite product containing the active ingredients Pyrethrins and Piperonyl Butoxide into the ears of 3 puppies 2 weeks ago (about 4/14/08). Per the reporter, all 3 puppies had developed vomiting and diarrhea within 48 hrs of product use. The 1st puppy (1st subform III), had been evaluated by a veterinarian on 4/15. Exploratory surgery had been performed, during which time it was revealed that the puppy had a cirrhotic yellow liver. The puppy passed away on 4/17. The 2nd puppy (2nd subform III) had also been evaluated by the veterinarian on or about 4/16 for symptoms of vomiting and diarrhea. Lab work had shown a depressed white cell count and the puppy had been hospitalized through 4/18. According to the reporter, the veterinarian had told her the puppy had muscle tremors and seizures consistent with pyrethrin toxicosis. At the time of the call on 4/28, the 2nd puppy had improved but was still on antibiotics. The 3rd puppy (3rd subform III) had experienced hair loss around one ear and eye in addition to the initial vomiting and diarrhea. The reporter did not reveal during the call whether or not the 3rd puppy had ever been evaluated by veterinarian. The reporter requested and was given information about the company's reimbursement protocol. Several follow-up calls were placed, but no return calls were ever received. Note: The 2nd and 3rd puppy are siblings (born 12/23/07).


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

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.33

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
  • Blood
    • Symptom - Leukopenia
  • Nervous and Muscular Systems
    • Symptom - Fasciculations
    • Symptom - Seizure

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?

Yes

14. b) How long was the animal hospitalized?

2

Day(s) / Jour(s)

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

1-16077601: The reporter called on 4/28/08 to report she had instilled a topical ear mite product containing the active ingredients Pyrethrins and Piperonyl Butoxide into the ears of 3 puppies 2 weeks ago (about 4/14/08). Per the reporter, all 3 puppies had developed vomiting and diarrhea within 48 hrs of product use. The 1st puppy (1st subform III), had been evaluated by a veterinarian on 4/15. Exploratory surgery had been performed, during which time it was revealed that the puppy had a cirrhotic yellow liver. The puppy passed away on 4/17. The 2nd puppy (2nd subform III) had also been evaluated by the veterinarian on or about 4/16 for symptoms of vomiting and diarrhea. Lab work had shown a depressed white cell count and the puppy had been hospitalized through 4/18. According to the reporter, the veterinarian had told her the puppy had muscle tremors and seizures consistent with pyrethrin toxicosis. At the time of the call on 4/28, the 2nd puppy had improved but was still on antibiotics. The 3rd puppy (3rd subform III) had experienced hair loss around one ear and eye in addition to the initial vomiting and diarrhea. The reporter did not reveal during the call whether or not the 3rd puppy had ever been evaluated by veterinarian. The reporter requested and was given information about the company's reimbursement protocol. Several follow-up calls were placed, but no return calls were ever received. Note: The 2nd and 3rd puppy are siblings (born 12/23/07).


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

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.33

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
  • Skin
    • Symptom - Hair loss

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

1-16077601: The reporter called on 4/28/08 to report she had instilled a topical ear mite product containing the active ingredients Pyrethrins and Piperonyl Butoxide into the ears of 3 puppies 2 weeks ago (about 4/14/08). Per the reporter, all 3 puppies had developed vomiting and diarrhea within 48 hrs of product use. The 1st puppy (1st subform III), had been evaluated by a veterinarian on 4/15. Exploratory surgery had been performed, during which time it was revealed that the puppy had a cirrhotic yellow liver. The puppy passed away on 4/17. The 2nd puppy (2nd subform III) had also been evaluated by the veterinarian on or about 4/16 for symptoms of vomiting and diarrhea. Lab work had shown a depressed white cell count and the puppy had been hospitalized through 4/18. According to the reporter, the veterinarian had told her the puppy had muscle tremors and seizures consistent with pyrethrin toxicosis. At the time of the call on 4/28, the 2nd puppy had improved but was still on antibiotics. The 3rd puppy (3rd subform III) had experienced hair loss around one ear and eye in addition to the initial vomiting and diarrhea. The reporter did not reveal during the call whether or not the 3rd puppy had ever been evaluated by veterinarian. The reporter requested and was given information about the company's reimbursement protocol. Several follow-up calls were placed, but no return calls were ever received. Note: The 2nd and 3rd puppy are siblings (born 12/23/07).


To be determined by Registrant

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

Minor

19. Provide supplemental information here