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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-6267

2. Registrant Information.

Registrant Reference Number: ProPharma Group case:# 1-45598956

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.

15-SEP-16

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

6. Date incident was first observed.

12-SEP-16

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: HARTZ ULTRA GUARD PLUS FLEA & TICK SPRAY FOR CATS

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .07 %
    • TETRACHLORVINPHOS
      • Guarantee/concentration 1.08 %

7. b) Type of formulation.

Other (specify)

spray

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).

1-45598956 - Based on the owner's account, the attending veterinarian indicated the product was used on the cat four times in a "small amount of time" and it seemed like "they doused her."

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

7

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 - Death
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Eye
    • Symptom - Other
    • Specify - Anisocoria
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
  • Gastrointestinal System
    • Symptom - Salivating excessively

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?

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

1-45598956 - The reporter, a veterinarian, indicated a cat was exposed to an insecticidal spray product containing the active ingredients (S)-methoprene and tetrachlorvinphos. Five days before initial contact with the registrant, the cats owner sprayed her 7-pound, 3-year-old, female, domestic shorthair cat with the product. Three days before initial contact, the cat developed seizures, anorexia, and lethargy. Two days before initial contact, the cat developed anisocoria, muscle tremors, excessive salivation, and ataxia, so the owner bathed the cat and then brought her to the reporter for care. The reporter administered atropine and bathed the cat again, but the owners declined all other symptomatic and supportive care, and elected to take the cat home. On the day of initial contact with the registrant, the owner brought the cat back to the reporter as she still had ataxia and muscle tremors. The reporter was advised to bathe the cat again to remove any product, and treat symptomatically and supportively. The reporter was given instructions on submitting blood for cholinesterase testing provided by the registrant. One day after initial contact, the cat died. Instructions for submitting the cat for a necropsy was forwarded to the clinic. 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