Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0342

2. Registrant Information.

Registrant Reference Number: 160159366

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.

25-OCT-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

23-OCT-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 October 23, 2016 the owner used the product on the dog to treat for fleas.

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

Miniature Pinscher

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

8.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Skin
  • Symptom - Hair loss
  • Symptom - Dry skin
  • Symptom - Pruritus
  • Symptom - Other
  • Specify - Skin problems

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 October 23, 2016 the owner dried the dog off after bathing with the product and noticed the dog had developed alopecia and dry skin. Between October 23, 2016 and October 25, 2016 the owner provided symptomatic treatment (owner used a skin medication like an antibiotic or something similar- no label available). On October 24, 2016 the dog had developed pruritus. On October 25, 2016 the dog developed skin problems (blotches looking like chickenpox). The owner then contacted the Animal Product Safety Service (APSS) and stated the dog had received a regular bath 3 weeks prior. The APSS veterinarian stated may see allergic reaction in sensitive dogs and this dog's signs suggest a pre-existing dermatitis. The APSS assistant recommended taking the dog to the veterinarian, having the veterinarian call for information. The APSS assistant also recommended if the owner cannot get the dog into the veterinarian that day to try bathing the dog (regular dog shampoo) and then providing symptomatic care (can use baby oil diluted 1:12 and then applied to the skin and towel dry). The APSS assistant also stated that if signs persist she should have the dog seen by a veterinarian and treated appropriately. The APSS assistant further recommended calling back with questions and provided information (she emailed the owner the case number and follow up number so the owner could call the APSS to consult if she has any concerns).

---

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 dermatitis was considered to have a high likelihood of causing the clinical situation. Signs expected to be mild and self limiting.