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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-0364

2. Registrant Information.

Registrant Reference Number: 140091296

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.

22-JUL-14

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

21-JUL-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. 13922      PMRA Submission No.       EPA Registration No.

Product Name: Swat Fly Repellent Cream for Wounds and Sores

  • Active Ingredient(s)
    • DI-N-PROPYL ISOCINCHOMERONATE
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

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).

On July 15, 2014 the horse had surgery. On July 21, 2014 the horse went home and the attending veterinarian recommended the owner to apply fly cream on the stitches, which the owner did that evening.

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

Medical Professional

2. Type of animal affected

Horse / Cheval

3. Breed

Standardbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

475.0

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Edema
    • Specify - Edema of the Face

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

No

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 July 21, 2014 the owner noticed the horse developed edema of the face. The owner then contacted the attending veterinarian, who came out and provided dermal decontamination (rinsing the horse's face with water) and giving symptomatic care (anti-inflammatory injection). On July 22, 2014 he horse's edema of the face became milder. The attending veterinarian then called the Animal Product Safety Service (APSS) to see if hypersensitivity reactions have been seen with this product before. The APSS veterinarian stated as with any topical exposure, dermal irritation or hypersensitivity reactions are possible. The APSS veterinarian also stated paresthesia (abnormal tingling sensation) can also occur from topical pyrethrins. The APSS veterinarian recommended calling back with questions and she referred to the manufacturer to discuss the attending veterinarian's concerns over labeling of the product and financial compensation for medical care.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Product is 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.