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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-0365

2. Registrant Information.

Registrant Reference Number: 140123997

Registrant Name (Full Legal Name no abbreviations): Farnam Companies, Inc.

Address: 301 W. Osborn Road

City: Phoenix

Prov / State: Arizona

Country: USA

Postal Code: 85013

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

30-SEP-14

5. Location of incident.

Country: UNITED STATES

Prov / State: ALABAMA

6. Date incident was first observed.

20-SEP-14

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. 270-324

Product Name: Adams Flea and Tick Cleansing Shampoo for Cats and Kittens

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .75 %
    • PYRETHRINS
      • Guarantee/concentration .075 %
    • PYRIPROXYFEN
      • Guarantee/concentration .086 %

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).

On September 17, 2014 the owner bathed the kittens with the product, diluted with water and liquid dish washing detergent (LDWD).

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

Cat / Chat

3. Breed

Domestic Mediumhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.077

7. Weight (provide a range if necessary )

1.0

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 - Lethargy
    • Symptom - Weakness
    • Symptom - Hypothermia
    • 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

On September 20, 2014 the kitten developed lethargy, weakness, and hypothermia. On September 22, 2014 the kitten died. On September 30, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated although it is off label use death is not expected. The APSS veterinarian provided information and recommended a necropsy, which was unavailable.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Product was not considered to be related to causing the clinical situation. The APSS veterinarian stated that flea infestation was considered to have a medium likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Mediumhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.077

7. Weight (provide a range if necessary )

1.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • General
    • Symptom - Lethargy
    • Symptom - Weakness
    • Symptom - Hypothermia
    • 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

On September 22, 2014 the kitten developed lethargy, weakness, and hypothermia. On September 23, 2014 the kitten died. On September 30, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated although it is off label use death is not expected. The APSS veterinarian provided information and recommended a necropsy, which was unavailable.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Product was not considered to be related to causing the clinical situation. The APSS veterinarian stated that flea infestation was considered to have a medium likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Mediumhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.077

7. Weight (provide a range if necessary )

1.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • General
    • Symptom - Lethargy
    • Symptom - Weakness
    • Symptom - Hypothermia
    • 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

On September 22, 2014 the kitten developed lethargy, weakness, and hypothermia. On September 25, 2014 the kitten died. On September 30, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated although it is off label use death is not expected. The APSS veterinarian provided information and recommended a necropsy, which was unavailable.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Product was not considered to be related to causing the clinical situation. The APSS veterinarian stated that flea infestation was considered to have a medium likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Mediumhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.077

7. Weight (provide a range if necessary )

1.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • General
    • Symptom - Lethargy
    • Symptom - Weakness
    • Symptom - Hypothermia
    • 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

On September 22, 2014 the kitten developed lethargy, weakness, and hypothermia. On September 26, 2014 the kitten died. On September 30, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated although it is off label use death is not expected. The APSS veterinarian provided information and recommended a necropsy, which was unavailable.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Product was not considered to be related to causing the clinical situation. The APSS veterinarian stated that flea infestation was considered to have a medium likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected.