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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-4262

2. Registrant Information.

Registrant Reference Number: Prosar 1-19293072

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.

25-JUL-09

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSOURI

6. Date incident was first observed.

22-JUL-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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-147

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

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

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 either one or two cats on or about 7/20/09. Conflicting information was given from the 2 reporters (owner and veterinarian).

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

Unknown

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

  • Respiratory System
    • Symptom - Panting
    • Symptom - Mouth breathing
  • General
    • Symptom - Death
  • Respiratory System
    • Symptom - Other
    • Specify - bilateral edematous vocal folds
  • Renal System
    • Symptom - Other
    • Specify - bruising/hemorrage of the lining of bladder
  • Cardiovascular System
    • Symptom - Other
    • Specify - petechiation of the atria of the heart
  • Eye
    • Symptom - Pupil dilation
    • Specify - Fixed and dilated pupils

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?

Unknown

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

1-19293072: The reporter, the animal owner, called on 7/25/09 to report the exposure of her 12 year old cat (┐┐┐Thelma?, 2nd subform III) to an OTC flea and tick product containing the active ingredient Methoprene. According to the reporter, the product had been applied 5 days previously. Two days after product application, the cat had developed intermittent episodes of open mouth breathing. The owner had not yet tried to bathe the cat to remove the product, but did indicate the cat still had live fleas. The safety profile of this (insect growth regulator) active ingredient was discussed, including the fact that insect growth regulators treat flea eggs and larvae only, not adult fleas. A recommendation was made to take the cat to a veterinarian as soon as possible. The owner┐┐┐s veterinarian then called on 7/27/09 to report the death of one of the owner┐┐┐s cats (┐┐┐Louise?, 1st subform III). The identification of the second patient was verified with the veterinarian, and the previous call from the owner regarding the initial patient (┐┐┐Thelma?) was discussed. Clarification was obtained that, as far as the veterinarian knew, the owner had not reported any breathing problems with ┐┐┐Thelma?. An annual examination with vaccinations was even scheduled for ┐┐┐Thelma? on 8/1/09. According to the veterinarian, ┐┐┐Louise? had experienced breathing problems (panting and open mouth breathing) after the product had been applied. She had been taken to an emergency clinic, where she had been bathed and placed on oxygen. Bloodwork was also done. On 7/24/09 the owner called the veterinarian to report that the cat had additional breathing problems, but "Louise" died while in transit to the veterinarian. On presentation her pupils were fixed and dilated, and intubation was attempted but was unsuccessful. The veterinarian conducted an in-clinic necropsy. His findings included: 1) bilateral edematous vocal folds, 2) bruising/hemorrhage of the lining of bladder, and 3) petechiation of the atria of the heart. The safety profile of the active ingredient was discussed with the veterinarian, as was the company-sponsored necropsy program. The appropriate forms were faxed to the veterinarian. No additional information is available.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The product was applied to either one or two cats on or about 7/20/09. Conflicting information was given from the 2 reporters (owner and veterinarian).

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 )

12

7. Weight (provide a range if necessary )

16

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

  • Respiratory System
    • Symptom - Mouth breathing

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

1-19293072: The reporter, the animal owner, called on 7/25/09 to report the exposure of her 12 year old cat (┐┐┐Thelma?, 2nd subform III) to an OTC flea and tick product containing the active ingredient Methoprene. According to the reporter, the product had been applied 5 days previously. Two days after product application, the cat had developed intermittent episodes of open mouth breathing. The owner had not yet tried to bathe the cat to remove the product, but did indicate the cat still had live fleas. The safety profile of this (insect growth regulator) active ingredient was discussed, including the fact that insect growth regulators treat flea eggs and larvae only, not adult fleas. A recommendation was made to take the cat to a veterinarian as soon as possible. The owner┐┐┐s veterinarian then called on 7/27/09 to report the death of one of the owner┐┐┐s cats (┐┐┐Louise?, 1st subform III). The identification of the second patient was verified with the veterinarian, and the previous call from the owner regarding the initial patient (┐┐┐Thelma?) was discussed. Clarification was obtained that, as far as the veterinarian knew, the owner had not reported any breathing problems with ┐┐┐Thelma?. An annual examination with vaccinations was even scheduled for ┐┐┐Thelma? on 8/1/09. According to the veterinarian, ┐┐┐Louise? had experienced breathing problems (panting and open mouth breathing) after the product had been applied. She had been taken to an emergency clinic, where she had been bathed and placed on oxygen. Bloodwork was also done. On 7/24/09 the owner called the veterinarian to report that the cat had additional breathing problems, but "Louise" died while in transit to the veterinarian. On presentation her pupils were fixed and dilated, and intubation was attempted but was unsuccessful. The veterinarian conducted an in-clinic necropsy. His findings included: 1) bilateral edematous vocal folds, 2) bruising/hemorrhage of the lining of bladder, and 3) petechiation of the atria of the heart. The safety profile of the active ingredient was discussed with the veterinarian, as was the company-sponsored necropsy program. The appropriate forms were faxed to the veterinarian. No additional information is available.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The product was applied to either one or two cats on or about 7/20/09. Conflicting information was given from the 2 reporters (owner and veterinarian).