Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4152

2. Registrant Information.

Registrant Reference Number: PROSAR Case 1-16507855

Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Company

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.

10-AUG-08

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

10-AUG-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. 2596-151

Product Name: Advanced Care 3 in 1 Once A Month Flea and Tick Drops for Dogs 31-60lb

• 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).

The product was applied by a neighbor of the owner on 8/10/2008. The product indication is for use on dogs weighing 31 to 60lbs and was applied to an 8 week old 3lb puppy.

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

Terrier Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.17

7. Weight (provide a range if necessary )

3

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Melena
  • Symptom - Stomach pain
  • Specify - Abdominal pain

• Nervous and Muscular Systems
  • Symptom - Unresponsive
  • Specify - Unresponsive

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Bloody diarrhea

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?

Yes

14. b) How long was the animal hospitalized?

Unknown

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

1-16507855: The reporter called on 8/10/2008, to report exposure of his dog to a topical flea and tick product containing the active ingredient Phenothrin. According to the reporter, his neighbor applied product indicated for dogs weighing 31 to 60lbs to his 8 week old, 3lb Terrier mix puppy one hour prior to the call. The reporter had bathed the puppy twice with non-insecticidal pet shampoo. The safety profile was discussed in that some animal may show sensitivity to the active ingredient in the product. Symptoms can include dermal irritation and although not typical, animal sensitivity may include CNS symptoms of ataxia, tremors, hyperthermia or seizures. A recommendation was made to seek Veterinary care should symptoms develop. The reporter called back on 8/11/2008 and reported that the dog had experienced diarrhea through the night and was unresponsive that morning. A recommendation was made to have the dog seen immediately by a Veterinarian. On 8/11/2008 a call was received from the attending Veterinarian. The puppy had presented to his veterinary hospital with a painful abdomen, bloody diarrhea and was unresponsive. The safety profile of the product was discussed with the Veterinarian and supportive care was recommended. A follow-up call to the owner on 8/12/2008 revealed that the dog had been taken to a Veterinarian on 8/11/2008 and had died, according to his Veterinarian, from internal bleeding and Parvo.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here