Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7255

2. Registrant Information.

Registrant Reference Number: ProPharma Group case:# 1-45941791

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.

14-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

6. Date incident was first observed.

14-OCT-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-83

Product Name: HARTZ ULTRAGUARD FLEA & TICK COLLAR FOR CATS AND KITTENS - PURPLE SAFE

• Active Ingredient(s)
  • TETRACHLORVINPHOS
    • Guarantee/concentration 14.55 %

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

Product Name: HARTZ ULTRA ONESPOT GUARD FLEA EGG & FLEA LARVAE TREATMENT FOR CATS

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

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7. b) Type of formulation.

Liquid

Other (specify)

collar

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 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

Male

6. Age (provide a range if necessary )

5.5

7. Weight (provide a range if necessary )

5

lbs

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

• General
  • Symptom - Death

• Renal System
  • Symptom - Anuria

• Gastrointestinal System
  • Symptom - Weight loss

• Blood
  • Symptom - Anemia

• General
  • Symptom - Lethargy
  • Symptom - Vocalizing
  • Symptom - Weakness

• Skin
  • Symptom - Irritated skin
  • Symptom - Other
  • Specify - flea infestation

• Nervous and Muscular Systems
  • Symptom - Seizure

• Gastrointestinal System
  • Symptom - Constipation
  • Specify - No defecation
  • Symptom - Anorexia

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

1-45982122 - The reporter, a pet owner, indicated his cat was exposed to an insecticidal collar containing the active ingredient tetrachlorvinphos, and an insecticidal spot-on containing the active ingredient (S)-methoprene. Approximately one month before the day of initial contact with the registrant, the reporter applied the spot-on product to his 5-pound, 5.5-year-old, male domestic shorthair cat. Two days before the day of initial contact, the reporter applied the collar to the cat. Soon after the collar was applied, the cat became lethargic, stopped eating, and lost weight. The reporter was advised to get veterinary care for the pet and that this would be an unexpected reaction to the products. Four days after the day of initial contact, the reporter called to state the cat had started vocalizing and has not urinated or defecated in four days. He had not gotten veterinary care for the pet due to financial concerns. The reporter was advised to get immediate veterinary attention for the cat as the symptoms sounded very serious. A follow-up call was made eight days after the day of initial contact and the voice mail was full so a message was unable to be left. Another follow-up call was made nine days after initial contact and a voice mail was left for an update on the cat. The reporter called back that same day and indicated he had sought emergency veterinary care for the cat on the day he had last spoken to the registrant. The cats facial skin was irritated from flea bites, he was weak, and anemic. The cat was bathed and given a pill to get rid of the fleas, but the reporter did not know what other treatments were done to the cat. The reporter took the cat home after 2-3 hours at the emergency vet. The cat had a seizure and died five days after the day of initial contact with the registrant. The reporter brought the deceased cat to another veterinarian where a necropsy was performed. No necropsy results have been reported. No additional information is available.

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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