Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4175

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16422691

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.

21-JUL-08

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

21-JUL-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-150

Product Name: UltraGuard Pro Flea and Tick Drops Plus for Dogs and Puppies 4-15 lbs

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 2.3 %
  • D-PHENOTHRIN
    • Guarantee/concentration 85.7 %

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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 to a 2 month old 2.5 lb. puppy on 7/21/08. The product is designed to be used on animals 4-15 lbs.. It is not designed to be used on puppies less than 12 weeks of age.

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

Toy Fox Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.16

7. Weight (provide a range if necessary )

2.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Seizure

• General
  • Symptom - Vocalizing

• Nervous and Muscular Systems
  • Symptom - Unconsciousness

• General
  • Symptom - Death

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?

1

Day(s) / Jour(s)

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

1-16422691: The reporter, a veterinary technician, called on 7/21/08 to report the application of a topical flea and tick product containing the active ingredients Methoprene and Phenothrin to a 2 month old 2.5 lb male puppy earlier in the day. According to the reporter, the puppy had presented non-responsive with focal vocalizations and had been having seizures for 30 minutes. The attending veterinarian had started the puppy on IV fluids and had given IV Diazepam. They had attempted to wipe the puppy down with a wet cloth but had not yet been able to properly bathe the puppy. Seizures had persisted in spite of the current treatment. A recommendation was made to try Phenobarbital or to try masking the puppy down with a general anesthetic to control the seizures. It was further discussed that symptomatic and supportive care was needed, and that Diazepam would only be recommended if no other options were available as it tends to not be as effective for seizure control. An additional recommendation was made to bathe the puppy with a non-medicated shampoo, and to instruct the owner that this product is not labeled for use in puppies younger than 12 weeks of age. The attending veterinarian called back about 5 hours later requesting information on how to control the puppy¿s breakthrough seizures. Per the veterinarian, IV Diazepam had been given several times followed by IV phenobarbital (per the earlier recommendations). The Phenobarbital had controlled the puppy for about 3 hours but then he had begun having breakthrough seizures. The veterinarian had tried additional IV Diazepam, which had controlled the puppy for an additional 1.25 hours. Focal vocalizations had then returned though the puppy had remained non-responsive. It was discussed that 1) a continuous rate infusion of either Diazepam or an anesthetic agent such as Propofol, or 2) placing the puppy under general anesthesia may be needed to fully control any seizures. A follow-up call on 7/22 revealed that the puppy had passed away. Note: The product used is designed for animals 4-15 lbs. It is not designed to be used on puppies less than 12 weeks of age.

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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