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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-8099

2. Registrant Information.

Registrant Reference Number: 160181218

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.

06-DEC-16

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW JERSEY

6. Date incident was first observed.

25-NOV-16

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. 270-349

Product Name: Bio Spot Pyrethrin Dip with Aloe Vera Extract Lanolin and Sunscreens

  • Active Ingredient(s)
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration 5.7 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 3.74 %
    • PYRETHRINS
      • Guarantee/concentration .97 %

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 November 24, 2016 the owner dipped the kitten with the product following label instructions.

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

Cat / Chat

3. Breed

Feline Domestic Unspecified

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.375

7. Weight (provide a range if necessary )

5.5

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
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 November 25, 2016 the kitten became lethargic. On November 26, 2016 the kitten developed ataxia. On December 2, 2016 the owner took the kitten to the veterinary clinic where fluid therapy was done. On December 3, 2016 the kitten died. On December 6, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated low concentration of pyrethrins, potential for gastrointestinal (GI) upset if ingested. The APSS veterinarian also stated dermal hyperesthesia is possible. The APSS veterinarian additionally stated unlikely to see significant clinical signs like tremors or seizures from a properly applied product. The APSS veterinarian finally stated the signs described are not consistent with a pyrethroid toxicity. The owner was unsure of what tests or findings the attending veterinarian had, but the kitten had rapidly declined. The APSS veterinarian recommended a necropsy (not possible as the cat had been buried and the owner didn't want to dig the body up), having the veterinarian call for information, and calling back with questions. The APSS veterinarian discussed with the owner that the case would be more accurately evaluated once records were received from the attending veterinarian.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected. On December 6, 2016 the attending veterinary staff contacted the APSS to discuss faxing the medical records to the APSS and stated she would need approval from the attending veterinarian. Later that day, the APSS received the faxed medical records from the clinic. On December 2, 2016 the kitten was hospitlialized, received fluid therapy and supportive care, and was given famotidine (given twice), maropitant, and nitenpyram. The attending veterinarian suspected feline infectious peritonitis (FIP) and possible severe congenital renal disease.