Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3645

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16102204

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.

04-MAY-08

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

03-MAY-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.

Product Name: UltraGuard Flea and Tick Drops for Dogs and Puppies 31-60 lbs.

• Active Ingredient(s)
  • 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 reporter applied the product to 2 dogs on 5/3/08. Only one dog (34 lbs, 2nd subform III) weighed within the listed weight range on the product label. The other dog (18 lbs, 1st subform III) weighed less than the listed weight range on the label.

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

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.38

7. Weight (provide a range if necessary )

18

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Loss of appetite

• Nervous and Muscular Systems
  • Symptom - Shakiness

• General
  • Symptom - Hiding
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

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

1-16102204: The reporter called on 5/4/08 to report he had applied a topical flea and tick product containing the active ingredient Phenothrin to his 4.5 month old puppy (1st subform III) the previous evening. According to the reporter, the puppy had vomited within 1-2 hours of application and had a depressed appetite. Prior to the call he had bathed the puppy with a non-medicated shampoo. The safety profile of the product was discussed with the reporter, including the fact that minor GI upset can occur if a pet licks themselves post-application. A recommendation was made to replace lost fluids with an electrolyte drink added to the puppy's drinking water, and to seek veterinary care if the symptoms worsened. A follow-up call was made on 5/5, at which time it was revealed that the puppy had passed away earlier in that day. The reporter's wife had been trying to hand feed him and had been giving him Pedialyte, but he had started shaking and trying to hide. The reporter had not taken the puppy into a veterinarian. The reporter then called back later on 5/5/08 to report that the 2nd dog to which he had applied the same product (also on 5/3/08) had now begun to develop a rash. A recommendation was made to bathe the dog (2nd subform III) in a mild non-insecticidal shampoo or dish soap, and to seek veterinary care if the symptoms persisted or worsened. Note: Only one of the dogs (2nd subform III) weighed within the listed weight range on the product label. The other dog (1st subform III) weighed less than the listed weight range on the label.

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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

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

34

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

• Skin
  • Symptom - Rash

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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

1-16102204: The reporter called on 5/4/08 to report he had applied a topical flea and tick product containing the active ingredient Phenothrin to his 4.5 month old puppy (1st subform III) the previous evening. According to the reporter, the puppy had vomited within 1-2 hours of application and had a depressed appetite. Prior to the call he had bathed the puppy with a non-medicated shampoo. The safety profile of the product was discussed with the reporter, including the fact that minor GI upset can occur if a pet licks themselves post-application. A recommendation was made to replace lost fluids with an electrolyte drink added to the puppy's drinking water, and to seek veterinary care if the symptoms worsened. A follow-up call was made on 5/5, at which time it was revealed that the puppy had passed away earlier in that day. The reporter's wife had been trying to hand feed him and had been giving him Pedialyte, but he had started shaking and trying to hide. The reporter had not taken the puppy into a veterinarian. The reporter then called back later on 5/5/08 to report that the 2nd dog to which he had applied the same product (also on 5/3/08) had now begun to develop a rash. A recommendation was made to bathe the dog (2nd subform III) in a mild non-insecticidal shampoo or dish soap, and to seek veterinary care if the symptoms persisted or worsened. Note: Only one of the dogs (2nd subform III) weighed within the listed weight range on the product label. The other dog (1st subform III) weighed less than the listed weight range on the label.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here