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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-6000

2. Registrant Information.

Registrant Reference Number: PROSAR Case #1-23999382

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.

Human

Domestic Animal

4. Date registrant was first informed of the incident.

02-SEP-10

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

02-SEP-10

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 Tick Spray for Cats

  • 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).

To be determined by Registrant

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

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Respiratory failure
    • Specify - "respiratory arrest"
  • Cardiovascular System
    • Symptom - Bradycardia
  • Nervous and Muscular Systems
    • Symptom - Numbness
    • Symptom - Paralysis

4. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Application

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

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

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

1-23999382- The reporter, a pet owner, indicates exposure of her animal and her self to an insecticide containing the active ingredient tetrachlorvinphos and methoprene. The caller indicates she applied the product, a topical flea and tick spray, to her cat twelve hours prior to her initial contact with the registrant. The four year old five pound female domestic shorthair cat (Sub-form III, #1) had developed signs of ataxia, weakness and vomiting within thirty minutes of the initial contact with the registrant. The caller was informed this would be unexpected following routine use of the product according to the label instructions. She was advised to wash her animal with a non insecticidal shampoo and seek prompt veterinary care. On routine follow up the next day the reporter (Sub-form II, #1) indicated the animal was still weak and had vomited once that day. She had not brought the animal to the veterinarian. She also reported she had developed symptoms of ┐┐┐respiratory failure, slow heart rate, whole body paralysis, and numbness? the morning of the follow up. She had indicated her heath care aide had called 911. It was not clarified what care she had received but she commented she was at home and was ┐┐┐OK?. The reporter gave a disjointed history and indicates she was disabled from a gunshot wound she suffered two years prior. It was unclear if she was indicating her symptoms were related to an exposure. No further information is available.

To be determined by Registrant

14. Severity classification.

Major

15. 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 )

4

7. Weight (provide a range if necessary )

5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Muscle weakness
  • Gastrointestinal System
    • Symptom - Vomiting

12. How long did the symptoms last?

Unknown / Inconnu

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

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

1-23999382- The reporter, a pet owner, indicates exposure of her animal and her self to an insecticide containing the active ingredient tetrachlorvinphos and methoprene. The caller indicates she applied the product, a topical flea and tick spray, to her cat twelve hours prior to her initial contact with the registrant. The four year old five pound female domestic shorthair cat (Sub-form III, #1) had developed signs of ataxia, weakness and vomiting within thirty minutes of the initial contact with the registrant. The caller was informed this would be unexpected following routine use of the product according to the label instructions. She was advised to wash her animal with a non insecticidal shampoo and seek prompt veterinary care. On routine follow up the next day the reporter (Sub-form II, #1) indicated the animal was still weak and had vomited once that day. She had not brought the animal to the veterinarian. She also reported she had developed symptoms of ┐┐┐respiratory failure, slow heart rate, whole body paralysis, and numbness? the morning of the follow up. She had indicated her heath care aide had called 911. It was not clarified what care she had received but she commented she was at home and was ┐┐┐OK?. The reporter gave a disjointed history and indicates she was disabled from a gunshot wound she suffered two years prior. It was unclear if she was indicating her symptoms were related to an exposure. No further 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