Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-3992

2. Registrant Information.

Registrant Reference Number: Prosar 1-19551601

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-AUG-09

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

14-AUG-09

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. 2596-147

Product Name: UltraGuard One Spot Flea Egg/Larvae Treatment for Cats/Kittens

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 2.9 %

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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 4 cats on 08/11/2009.

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

Cat / Chat

3. Breed

Himalayan

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• General
  • Symptom - Vocalizing

• Respiratory System
  • Symptom - Heavy breathing
  • Specify - "Breathing deep and not as often as normal"

• Nervous and Muscular Systems
  • Symptom - Muscle spasm

• General
  • 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

1-19551601: A reporter (cat owner) called on 08/17/2009 to report the exposure of her 4 cats to a flea egg and larvae product containing the active ingredient Methoprene. According to the reporter, the product was applied to the cats on 08/11/2009. On 08/14/2009, Cat #1 (1st Subform III) was vocalizing and breathing deeply and less often than normal. Cat #1 began to spasm on 08/15/2009 and died on 08/16/2009. The cat was not evaluated by a veterinarian. On 08/17/2009, Cat #2 (2nd Subform III) began acting lethargic. The other 2 cats were asymptomatic at the time of the initial report. The reporter was advised that the active ingredient has little to no mammalian toxicity, and adverse reactions would not be expected. A recommendation was made to bathe the Cat #2 with a hand dish soap. The reporter was also advised that if the signs persist, Cat #2 should be evaluated by a veterinarian to determine the cause of the signs. The reporter called again on 08/17/2009 to report that Cat #2 had been bathed and died a short time later. The reporter was advised to consider necropsy to determine the cause of death. The reporter called on 08/21/2009 to report that Cat #3 (3rd Subform III) had died on 08/20/2009. It is unknown what signs Cat #3 had prior to death. All 4 cats had been bathed after the initial report. At the time of the most recent report, Cat #4 was lethargic and not eating. None of the cats had been evaluated by a veterinarian since the start of their signs. The reporter was again advised that the signs reported are not expected with product use. The reporter was encouraged to have Cat #4 evaluated by a veterinarian. The reporter called back on 08/31/2009 to report that Cat #4 had died on 08/30/2009. Cat #4 had not been evaluated by a veterinarian. 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

Cat / Chat

3. Breed

Himalayan

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4

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

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

• 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

1-19551601: A reporter (cat owner) called on 08/17/2009 to report the exposure of her 4 cats to a flea egg and larvae product containing the active ingredient Methoprene. According to the reporter, the product was applied to the cats on 08/11/2009. On 08/14/2009, Cat #1 (1st Subform III) was vocalizing and breathing deeply and less often than normal. Cat #1 began to spasm on 08/15/2009 and died on 08/16/2009. The cat was not evaluated by a veterinarian. On 08/17/2009, Cat #2 (2nd Subform III) began acting lethargic. The other 2 cats were asymptomatic at the time of the initial report. The reporter was advised that the active ingredient has little to no mammalian toxicity, and adverse reactions would not be expected. A recommendation was made to bathe the Cat #2 with a hand dish soap. The reporter was also advised that if the signs persist, Cat #2 should be evaluated by a veterinarian to determine the cause of the signs. The reporter called again on 08/17/2009 to report that Cat #2 had been bathed and died a short time later. The reporter was advised to consider necropsy to determine the cause of death. The reporter called on 08/21/2009 to report that Cat #3 (3rd Subform III) had died on 08/20/2009. It is unknown what signs Cat #3 had prior to death. All 4 cats had been bathed after the initial report. At the time of the most recent report, Cat #4 was lethargic and not eating. None of the cats had been evaluated by a veterinarian since the start of their signs. The reporter was again advised that the signs reported are not expected with product use. The reporter was encouraged to have Cat #4 evaluated by a veterinarian. The reporter called back on 08/31/2009 to report that Cat #4 had died on 08/30/2009. Cat #4 had not been evaluated by a veterinarian. 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

Cat / Chat

3. Breed

Unknown breed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

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

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

• General
  • 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

1-19551601: A reporter (cat owner) called on 08/17/2009 to report the exposure of her 4 cats to a flea egg and larvae product containing the active ingredient Methoprene. According to the reporter, the product was applied to the cats on 08/11/2009. On 08/14/2009, Cat #1 (1st Subform III) was vocalizing and breathing deeply and less often than normal. Cat #1 began to spasm on 08/15/2009 and died on 08/16/2009. The cat was not evaluated by a veterinarian. On 08/17/2009, Cat #2 (2nd Subform III) began acting lethargic. The other 2 cats were asymptomatic at the time of the initial report. The reporter was advised that the active ingredient has little to no mammalian toxicity, and adverse reactions would not be expected. A recommendation was made to bathe the Cat #2 with a hand dish soap. The reporter was also advised that if the signs persist, Cat #2 should be evaluated by a veterinarian to determine the cause of the signs. The reporter called again on 08/17/2009 to report that Cat #2 had been bathed and died a short time later. The reporter was advised to consider necropsy to determine the cause of death. The reporter called on 08/21/2009 to report that Cat #3 (3rd Subform III) had died on 08/20/2009. It is unknown what signs Cat #3 had prior to death. All 4 cats had been bathed after the initial report. At the time of the most recent report, Cat #4 was lethargic and not eating. None of the cats had been evaluated by a veterinarian since the start of their signs. The reporter was again advised that the signs reported are not expected with product use. The reporter was encouraged to have Cat #4 evaluated by a veterinarian. The reporter called back on 08/31/2009 to report that Cat #4 had died on 08/30/2009. Cat #4 had not been evaluated by a veterinarian. 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

Cat / Chat

3. Breed

Himalayan

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• 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

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

1-19551601: A reporter (cat owner) called on 08/17/2009 to report the exposure of her 4 cats to a flea egg and larvae product containing the active ingredient Methoprene. According to the reporter, the product was applied to the cats on 08/11/2009. On 08/14/2009, Cat #1 (1st Subform III) was vocalizing and breathing deeply and less often than normal. Cat #1 began to spasm on 08/15/2009 and died on 08/16/2009. The cat was not evaluated by a veterinarian. On 08/17/2009, Cat #2 (2nd Subform III) began acting lethargic. The other 2 cats were asymptomatic at the time of the initial report. The reporter was advised that the active ingredient has little to no mammalian toxicity, and adverse reactions would not be expected. A recommendation was made to bathe the Cat #2 with a hand dish soap. The reporter was also advised that if the signs persist, Cat #2 should be evaluated by a veterinarian to determine the cause of the signs. The reporter called again on 08/17/2009 to report that Cat #2 had been bathed and died a short time later. The reporter was advised to consider necropsy to determine the cause of death. The reporter called on 08/21/2009 to report that Cat #3 (3rd Subform III) had died on 08/20/2009. It is unknown what signs Cat #3 had prior to death. All 4 cats had been bathed after the initial report. At the time of the most recent report, Cat #4 was lethargic and not eating. None of the cats had been evaluated by a veterinarian since the start of their signs. The reporter was again advised that the signs reported are not expected with product use. The reporter was encouraged to have Cat #4 evaluated by a veterinarian. The reporter called back on 08/31/2009 to report that Cat #4 had died on 08/30/2009. Cat #4 had not been evaluated by a veterinarian. 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