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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-7751

2. Registrant Information.

Registrant Reference Number: PROSAR Case 1-15119480

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.

18-JUL-07

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

17-JUL-07

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. 26490      PMRA Submission No.       EPA Registration No.

Product Name: Control Pet Care System One Spot for Dogs + Puppies Over 14 kg

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PERMETHRIN

7. b) Type of formulation.

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

Mixed Breed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

90

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Skin
    • Symptom - Itchy skin
  • Gastrointestinal System
    • Symptom - Anorexia
  • Eye
    • Symptom - Pupil dilation
  • Nervous and Muscular Systems
    • Symptom - Difficulty getting up

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

Not recovered / Non rétabli

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

Caller applied the product to her 2 dogs that were heavily infested with fleas yesterday morning, 7-17-07. "Koda"-a male 2 year old 110# Lab mix developed severe scratching/itching, pupils dilated, loss of appetite, not wanting to drink much water, not willing to get up and walk or lift his head, scratching himself that he has a bleeding sore on his back that is oozing and has hair loss. He had been bathed with soap and water and then an oatmeal bath yesterday . "Tanna" a female 2 year old 90# Lab mix developed symptoms of severe scratching/itching, not willing to get up and move around much, pupils dilated, and not eating much food or drinking water. She had been bathed with soap and water and then an oatmeal bath yesterday. Caller states the product DID NOT work! Caller has a Vet appt on Friday, 7-20-07 to evaluate/treat the dogs. NOTE: Caller contacted her Veterinarian and was told by the that the product she applied to both dogs was not approved for Veterinary use in Canada. They recommend to bath the dogs. Her Veterinarian told her to come in for Capstar tablets to remove the fleas quickly and then apply Revolution to both of them. Caller again repeated that her Veterinarian and 5 other Veterinarians told her the product is NOT approved for dogs in Canada Caller did admit she bought it in Canada at a local store and (name) stated to the caller if a product was not approved to be sold in this store then the product would not have been on the store shelf. Caller went on to ask "why is this product still on the market, how can this product be used on dogs if these symptoms on her dog's developed, etc.," she described and she went on and on with more to say. Assessment: Discussed with the caller that the 2 dog's symptoms will be documented for (name). This product may cause a slight skin irritation. Product contains a pyrethyroid which may cause a parathesia or "pins and needles" effect such as a burning/tingling sensation to the skin. - The feeling of the animal being uncomfortable may cause behavior changes such as: excessive scratching, neck and back rolling on the floor, vocalization or agitation. If the animal has been excessively scratching it may be difficult to determine if the visible changes to the skin such as erythema are the result of the scratching or from true dermatitis from the product. - True parathesias typically do not result in any visible changes to the skin's appearance. - Symptoms typically resolve on their own in 2-48 hrs. - Some of the symptoms as reported and described are not typical of the product. Additional information provided by (name): Gave new symptoms, the dogs eyes were not red, but the pupils are dilated.


To be determined by Registrant

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

Moderate

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

Mixed Breed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

110

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Eye
    • Symptom - Pupil dilation
  • Skin
    • Symptom - Bleeding
    • Symptom - Irritated skin
  • Gastrointestinal System
    • Symptom - Anorexia
  • Skin
    • Symptom - Hair loss

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

Not recovered / Non rétabli

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

Caller applied the product to her 2 dogs that were heavily infested with fleas yesterday morning, 7-17-07. "Koda"-a male 2 year old 110# Lab mix developed severe scratching/itching, pupils dilated, loss of appetite, not wanting to drink much water, not willing to get up and walk or lift his head, scratching himself that he has a bleeding sore on his back that is oozing and has hair loss. He had been bathed with soap and water and then an oatmeal bath yesterday . "Tanna" a female 2 year old 90# Lab mix developed symptoms of severe scratching/itching, not willing to get up and move around much, pupils dilated, and not eating much food or drinking water. She had been bathed with soap and water and then an oatmeal bath yesterday. Caller states the product DID NOT work! Caller has a Vet appt on Friday, 7-20-07 to evaluate/treat the dogs. NOTE: Caller contacted her Veterinarian and was told by the that the product she applied to both dogs was not approved for Veterinary use in Canada. They recommend to bath the dogs. Her Veterinarian told her to come in for Capstar tablets to remove the fleas quickly and then apply Revolution to both of them. Caller again repeated that her Veterinarian and 5 other Veterinarians told her the product is NOT approved for dogs in Canada Caller did admit she bought it in Canada at a local store and (name) stated to the caller if a product was not approved to be sold in this store then the product would not have been on the store shelf. Caller went on to ask "why is this product still on the market, how can this product be used on dogs if these symptoms on her dog's developed, etc.," she described and she went on and on with more to say. Assessment: Discussed with the caller that the 2 dog's symptoms will be documented for (name). This product may cause a slight skin irritation. Product contains a pyrethyroid which may cause a parathesia or "pins and needles" effect such as a burning/tingling sensation to the skin. - The feeling of the animal being uncomfortable may cause behavior changes such as: excessive scratching, neck and back rolling on the floor, vocalization or agitation. If the animal has been excessively scratching it may be difficult to determine if the visible changes to the skin such as erythema are the result of the scratching or from true dermatitis from the product. - True parathesias typically do not result in any visible changes to the skin's appearance. - Symptoms typically resolve on their own in 2-48 hrs. - Some of the symptoms as reported and described are not typical of the product. Additional information provided by (name): Gave new symptoms, the dogs eyes were not red, but the pupils are dilated.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here