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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0078

2. Registrant Information.

Registrant Reference Number: 160189810

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-DEC-16

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

22-DEC-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. 270-373

Product Name: Just One Bite II Bait Chunk

  • Active Ingredient(s)
    • BROMADIOLONE
      • Guarantee/concentration .005 %

7. b) Type of formulation.

Bait

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - Out Home / Rés - à l'ext.maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On December 21, 2016 the owner ran over one of the bait blocks with her tire and crumbled it. On December 22, 2016 the owner saw the dog licking up an unknown amount of the product powder.

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

Pomeranian

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12.0

7. Weight (provide a range if necessary )

7.5

lbs

8. Route(s) of exposure

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Trembling
    • Symptom - Ataxia
    • Symptom - Seizure
  • General
    • Symptom - Hyperthermia
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
    • Symptom - Recumbent
    • Symptom - Unresponsive
  • Blood
    • Symptom - Other
    • Specify - Hemoconcentration
    • Symptom - Hyperglycemia
    • Symptom - Hypernatremia
    • Symptom - Other
    • Specify - Elevated Blood Urea Nitrogen
    • Symptom - Other
    • Specify - Hyperkalemia
    • Symptom - Acidosis
    • Symptom - Hypocalcemia
  • Renal System
    • Symptom - Creatinine increased
    • Specify - Elevated Creatinine
  • 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?

2

Day(s) / Jour(s)

15. Outcome of the incident

Died

16. How was the animal exposed?

Accidental ingestion/Ingestion accident.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On December 22, 2016 the owner took the dog to the veterinary clinic, where they induced emesis, gave activated charcoal, and then gave vitamin K1. A few hours later the dog's temperature was measured at 103.6 degrees Fahrenheit (deg F). Later that day, the dog developed trembling, ataxia, and had a seizure. The owner then took the dog to the emergency veterinary clinic where intralipids, mannitol, and midazolam (did not help too much) were given. The owner then contacted the Animal Product Safety Service (APSS) to discuss the case. The APSS veterinarian stated risk is for coagulopathy in 3-5 days. The APSS assistant recommended the owner have the veterinarian call for information. Later that day, the attending emergency veterinarian called the APSS to discuss the case. The attending emergency veterinarian stated blood work at the previous veterinary clinic revealed the following; the dog's serum sodium was measured at 154.0 milliequivalents of solute per liter of solvent (mEq/L), had hemoconcentration with the dog's hematocrit measured at 72.0 percentage of volume to volume (% v/v), total protein was measured at 7.6 grams per deciliter (g/dL), had hyperglycemic with the serum glucose was measured at 319.0 milligrams per deciliter (mg/dL), had hypernatremia, with the serum creatinine measured at 1.3 mg/dL, had elevated blood urea nitrogen, with the blood nitrogen was measured at 53.0 mg/dL, had hyperkalemia, with serium potassium measured at 7.7 mEq/L, and serium chloride measured at 121.0 mEq/L. Later that day, the dog developed acidosis, hypocalcemia, with serum calcium measured at 0.79 mEq/L, and an elevated creatinine. The APSS veterinarian recommended a further diagnostic evaluation (urinalysis (U/A)), fluid therapy, monitoring electrolytes, supportive care, calling back with questions, and obtaining additional information (the dog's recent history from the owner, any polyuria and polydipsia (PU/PD), other signs, weight loss, etc.)


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. On December 24, 2016 an APSS assistant contacted the emergency veterinary clinic to follow-up. The emergency clinic receptionist stated stated that the attending emergency veterinarian was not in, the owner had financial restraints and declined doing any further diagnostic testing after initial blood work. The owner had elected to just continue supportive care and fluid therapy. On December 23, 2016 the dog died. The emergency clinic receptionist stated the owner was picking up the dog's body from the clinic so a necropsy was not possible The APSS veterinary assistant consulted with an APSS veterinarian who inquired whether the dog had urinated while hospitalized. The emergency clinic receptionist stated that according to the records, she did produce a large amount of urine overnight on December 22, 2016.