Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4545

2. Registrant Information.

Registrant Reference Number: ProPharma Group case:# 1-44742371

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.

06-JUL-16

5. Location of incident.

Country: UNITED STATES

Prov / State: ALABAMA

6. Date incident was first observed.

03-JUL-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. 2596-151

Product Name: HARTZ ULTRAGUARD FLEA & TICK DROPS FOR DOGS AND PUPPIES 31-60 LBS

• Active Ingredient(s)
  • D-PHENOTHRIN
    • Guarantee/concentration 85.7 %

---

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 III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Airedale Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

44

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
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• Respiratory System
  • Symptom - Laboured breathing

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Respiratory System
  • Symptom - Coughing
  • Symptom - Wheezing

• Cardiovascular System
  • Symptom - Abnormally fast heart rate

• Nervous and Muscular Systems
  • Symptom - Muscle tremors

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?

Unknown

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

1-44742371 - The reporter, a pet owner, indicated her dog was exposed to an insecticidal spot-on product containing the active ingredient D-phenothrin. The reporter applied the product to her 6-year-old, 44-pound, female, Airedale Terrier dog five days before initial contact with the registrant. Three days before the initial contact with the registrant, the dog developed lethargy, anorexia, ataxia, labored breathing, coughing, and wheezing. The reporter bathed the dog, and she seemed a bit better. One day before initial contact, the reporter took the dog to a veterinarian who said the dogs lab work and radiographs were normal, but the dogs heartrate was elevated. The dog was prescribed antibiotics and given an injection. The reporter did not start the antibiotics. On the day of initial contact with the registrant, the dog had developed muscle tremors, and her breathing was slightly better. The reporter was advised to seek veterinary care for the dog at a specialty center as her symptoms were very concerning. The product might cause anorexia and lethargy, and at higher doses ataxia, but would not be expected to cause breathing problems. The reporter said she was unlikely to seek advanced veterinary care due to financial concerns. On follow-up call eight days later, the reporter said the dog had died three days after initial contact. 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