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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0157

2. Registrant Information.

Registrant Reference Number: 160133413

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

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

Domestic Animal

4. Date registrant was first informed of the incident.

06-SEP-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

06-SEP-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. 19209      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea & Tick Shampoo

  • Active Ingredient(s)
    • 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 September 3, 2016 the owners noticed the dog had fleas, so they inappropriately bathed the dog twice with the shampoo about 5 hours apart. On September 4, 2016 the owners noticed the dog still had fleas, so they inappropriately bathed the dog again two more times.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7.5

7. Weight (provide a range if necessary )

4.1

kg

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
  • Gastrointestinal System
    • Symptom - Loss of appetite
  • Skin
    • Symptom - Erythema
  • General
    • Symptom - Discomfort
  • Nervous and Muscular Systems
    • Symptom - Trembling

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

Not recovered / Non rétabli

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 5, 2016 the owner applied a flea and tick topical on the dog that had expired in 2014. On September 6, 2016 the dog developed symptoms. Shortly after the attending veterinarian called the Animal Product Safety Service (APSS) to discuss the case. The attending veterinarian stated the owner gives the dog supplements; iodine, omega 3 fatty acids, an unknown chicken flavored supplement for fleas. The attending veterinarian also stated the owner had been giving the dog a cholecalciferol (vitamin D 100,000 international unit (IU) per 6 drops) 1 drop once daily with an unknown start date. The APSS veterinarian stated with the shampoo we can see a dermal reaction, lethargy, and twitching. The APSS veterinarian stated with chronic use of cholecalciferol we could see hypercalcemia, hyperphosphatemia, and acute kidney injury. The APSS veterinarian also stated calcification of the myocardium may cause arrhythmias and aortic calcification can lead to rupture of the artery; death may occur weeks or months later from these effects. The APSS veterinarian recommended bathing the dog, giving flea treatment (oral flea control), monitoring the dog at the veterinary facility, completing a diagnostic evaluation including a chemistry profile, providing symptomatic and supportive care, giving fluid therapy, and calling back with questions.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the cholecalciferol was considered to have an unknown likelihood of causing the clinical situation. On September 7, 2016 the owner called the APSS and stated that the dog had been lethargic all day and was wondering if activated charcoal (AC) would be indicated. The APSS veterinarian discussed with the owner that AC is usually used for oral intoxications within a few hours of ingestion. The APSS veterinarian discussed with the owner that the signs are not what we would typically expect from the shampoo exposure. At this time, no records have been received.