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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3021

2. Registrant Information.

Registrant Reference Number: 130066671

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.

21-MAY-13

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

18-MAY-13

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. 26922      PMRA Submission No.       EPA Registration No.

Product Name: Bio Spot For Small Dogs Weighing Less Than 15 Kg

  • Active Ingredient(s)
    • PERMETHRIN
    • PYRIPROXYFEN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.5

Units: mL

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 May 18, 2013 the owner applied the product to the dog to prevent fleas.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

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 )

8.0

7. Weight (provide a range if necessary )

12.0

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

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

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus
  • Gastrointestinal System
    • Symptom - Diarrhea
    • Specify - Soft Feces
    • Symptom - Other
    • Specify - Oily Feces
    • Symptom - Vomiting
    • Symptom - Loss of appetite
  • General
    • Symptom - Subdued

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

On May 18, 2013 the owner applied Bio Spot for Small Dogs as a preventative measure against fleas; the use was appropriate. A few hours later the owner noticed that the dog was experiencing pruritus around the application site, but there was no redness or irritation to the skin at the application site. On May 19, 2013 the owner noticed that the dog had soft and oily feces on and off all day, vomited a clear liquid once, was inappetent and did not eat anything other than regular dog food that night, and was subdued. When the owner observed those signs, she cleaned the dog with a human shampoo and used a wet washcloth to wipe the coat down. On May 20, 2013 the owner noticed that the dog's feces were back to normal and his appetite had returned. At that time, the owner also bathed the dog with a dog shampoo. Later that evening, the owner noticed that the dog's pruritus was milder. The dog remained subdued. On May 21, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that local dermal irritation, redness, itching, and paresthesia could be seen. The APSS technician recommended that the owner monitor the dog at home, apply vitamin E to the application site 2 to 3 times a day, give 11 to 12 milligrams (mg) of Diphenhydramine every 8 to 12 hours, and call back with questions or if there was no improvement in signs within 24 hours.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a medium likelihood of causing the clinical situation. A follow up was not performed, because signs were expected to be mild and self-limiting. Therefore, the outcome of this case is unknown.