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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4232

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16273668

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.

12-JUN-08

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

05-JUN-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. 2596-140

Product Name: UltraGuard Plus Flea and Tick Spray for Dogs 16 fl. oz.

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration ,07 %
    • TETRACHLORVINPHOS
      • Guarantee/concentration 1,08 %

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 had been applied to five 6 week old puppies about 1 week prior to the call. The product is designed to be used on puppies older than 12 weeks of age. In addition, the reporter had also used a Sergeant's flea shampoo several times on the lactating bitch (nursing mother dog).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Mixed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.13

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness
    • Symptom - Trembling
  • 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

1-16273668: The reporter called on 6/12/08 to report the application of a topical flea and tick product containing the active ingredients Methoprene and Tetrachlorvinphos to a litter of now 7 week old puppies approximately 1 week previously. According to the reporter, she had sprayed the puppies with the product 1 week ago and within minutes of application the puppies had become ataxic. The ataxia had spontaneously resolved within several minutes. The puppies had then been asymptomatic until 6/11, when one (1st subform III) had started to tremble and vocalize, had become very weak and had passed away that day. This puppy had been born with congenital issues including an enlarged head and only 1 eye. The reporter believed the congenital issues were the result of the PREVIOUS owner exposing the bitch (mother dog) to drugs (inhalation) during her pregnancy. At the time of the call on 6/12, the reporter stated a second puppy (2nd subform III) had also developed symptoms subsequent to the exposure ¿ lethargy and drowsiness. The remaining 3 puppies (3rd subform III) had remained asymptomatic since their spontaneous recovery from ataxia 1 week previously. While the reporter had not used the product a second time on the puppies, she had used a non-company flea and tick shampoo several times on the nursing bitch (mother dog). The following recommendations were made: 1) discontinue use of ALL flea and tick products on the bitch and her puppies until the puppies reach 12 weeks of age, 2) have a veterinarian evaluate all the puppies immediately. Several follow-up calls were placed but none were returned.


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

Mixed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.13

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Lethargy
    • Symptom - Drowsiness

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

1-16273668: The reporter called on 6/12/08 to report the application of a topical flea and tick product containing the active ingredients Methoprene and Tetrachlorvinphos to a litter of now 7 week old puppies approximately 1 week previously. According to the reporter, she had sprayed the puppies with the product 1 week ago and within minutes of application the puppies had become ataxic. The ataxia had spontaneously resolved within several minutes. The puppies had then been asymptomatic until 6/11, when one (1st subform III) had started to tremble and vocalize, had become very weak and had passed away that day. This puppy had been born with congenital issues including an enlarged head and only 1 eye. The reporter believed the congenital issues were the result of the PREVIOUS owner exposing the bitch (mother dog) to drugs (inhalation) during her pregnancy. At the time of the call on 6/12, the reporter stated a second puppy (2nd subform III) had also developed symptoms subsequent to the exposure ¿ lethargy and drowsiness. The remaining 3 puppies (3rd subform III) had remained asymptomatic since their spontaneous recovery from ataxia 1 week previously. While the reporter had not used the product a second time on the puppies, she had used a non-company flea and tick shampoo several times on the nursing bitch (mother dog). The following recommendations were made: 1) discontinue use of ALL flea and tick products on the bitch and her puppies until the puppies reach 12 weeks of age, 2) have a veterinarian evaluate all the puppies immediately. Several follow-up calls were placed but none were returned.


To be determined by Registrant

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

Minor

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

Mixed

4. Number of animals affected

3

5. Sex

Unknown

6. Age (provide a range if necessary )

0.13

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia

12. How long did the symptoms last?

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

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

1-16273668: The reporter called on 6/12/08 to report the application of a topical flea and tick product containing the active ingredients Methoprene and Tetrachlorvinphos to a litter of now 7 week old puppies approximately 1 week previously. According to the reporter, she had sprayed the puppies with the product 1 week ago and within minutes of application the puppies had become ataxic. The ataxia had spontaneously resolved within several minutes. The puppies had then been asymptomatic until 6/11, when one (1st subform III) had started to tremble and vocalize, had become very weak and had passed away that day. This puppy had been born with congenital issues including an enlarged head and only 1 eye. The reporter believed the congenital issues were the result of the PREVIOUS owner exposing the bitch (mother dog) to drugs (inhalation) during her pregnancy. At the time of the call on 6/12, the reporter stated a second puppy (2nd subform III) had also developed symptoms subsequent to the exposure ¿ lethargy and drowsiness. The remaining 3 puppies (3rd subform III) had remained asymptomatic since their spontaneous recovery from ataxia 1 week previously. While the reporter had not used the product a second time on the puppies, she had used a non-company flea and tick shampoo several times on the nursing bitch (mother dog). The following recommendations were made: 1) discontinue use of ALL flea and tick products on the bitch and her puppies until the puppies reach 12 weeks of age, 2) have a veterinarian evaluate all the puppies immediately. Several follow-up calls were placed but none were returned.


To be determined by Registrant

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

Minor

19. Provide supplemental information here