Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-2716

2. Registrant Information.

Registrant Reference Number: Prosar 1-18788941

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.

11-JUN-09

5. Location of incident.

Country: UNITED STATES

Prov / State: OKLAHOMA

6. Date incident was first observed.

10-JUN-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 2 kittens on 06/09/2009 following exposure to a non-company flea shampoo.

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

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.29

7. Weight (provide a range if necessary )

3

lbs

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 - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Constipation
  • Specify - "Trying to use the litter box but nothing is coming out"

• General
  • Symptom - Death

• Renal System
  • Symptom - Low urine output
  • Specify - "Trying to use the litter box but nothing is coming out"

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

1-18788941: A reporter (kitten owner) called on 06/011/2009 to report the exposure of 2 kittens to a flea egg and larvae product containing the active ingredient Methoprene. According to the reporter, a non-company flea shampoo was used to bathe the kittens on 06/09/2009. The product was then applied to both kittens. On 06/10/2009, both kittens were very lethargic, not eating, and "trying to use the litter box but nothing is coming out." The reporter was advised that the product is an insect growth regulator and is not designed to affect adult fleas. Because the product has very little to no mammalian toxicity, it is not expected to result in reactions. A recommendation was made to bathe the kittens in a non-insecticidal shampoo. A recommendation was also made to have a veterinarian evaluate the kittens and consider other causes for their signs. Finally, it was recommended to contact the maker of the non-company shampoo to determine that product's toxic profile. On follow up on 06/12/2009, the reporter stated that both kittens had been bathed following the initial report. Cat #1 (1st Subform III) died overnight. Cat #2 (2nd Subform III) was taken to the veterinarian on 06/12/2009 who advised bathing the kitten a second time. At the time of the report, Cat #2 had been bathed again in Dawn dish soap. She was still lethargic but had eaten some. The reporter was advised again that the product has a very wide margin of safety and adverse effects are not anticipated. A recommendation was made to get information on the non-company shampoo and have Cat #2 re-evaluated in case hydration, appetite stimulants, or force feeding is needed. A recommendation was also made to consider necropsy to determine the cause of death for Cat #1. 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

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.29

7. Weight (provide a range if necessary )

3

lbs

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 - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• Renal System
  • Symptom - Low urine output
  • Specify - "Tyring to use the litter box but nothing is coming out."

• Gastrointestinal System
  • Symptom - Constipation
  • Specify - "Tyring to use the litter box but nothing is coming out."

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

1-18788941: A reporter (kitten owner) called on 06/011/2009 to report the exposure of 2 kittens to a flea egg and larvae product containing the active ingredient Methoprene. According to the reporter, a non-company flea shampoo was used to bathe the kittens on 06/09/2009. The product was then applied to both kittens. On 06/10/2009, both kittens were very lethargic, not eating, and "trying to use the litter box but nothing is coming out." The reporter was advised that the product is an insect growth regulator and is not designed to affect adult fleas. Because the product has very little to no mammalian toxicity, it is not expected to result in reactions. A recommendation was made to bathe the kittens in a non-insecticidal shampoo. A recommendation was also made to have a veterinarian evaluate the kittens and consider other causes for their signs. Finally, it was recommended to contact the maker of the non-company shampoo to determine that product's toxic profile. On follow up on 06/12/2009, the reporter stated that both kittens had been bathed following the initial report. Cat #1 (1st Subform III) died overnight. Cat #2 (2nd Subform III) was taken to the veterinarian on 06/12/2009 who advised bathing the kitten a second time. At the time of the report, Cat #2 had been bathed again in Dawn dish soap. She was still lethargic but had eaten some. The reporter was advised again that the product has a very wide margin of safety and adverse effects are not anticipated. A recommendation was made to get information on the non-company shampoo and have Cat #2 re-evaluated in case hydration, appetite stimulants, or force feeding is needed. A recommendation was also made to consider necropsy to determine the cause of death for Cat #1. 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