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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0155

2. Registrant Information.

Registrant Reference Number: 160124893

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.

22-AUG-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

19-AUG-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. 31985      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac InfeStop Topical Solution for Dogs Over 25 kg

  • Active Ingredient(s)
    • IMIDACLOPRID

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

Units: mL

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 August 18, 2016 the owner applied the product onto the dog after noticing he had been scratching at himself.

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

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9.0

7. Weight (provide a range if necessary )

80.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus
    • Specify - Rubbing Application Site
    • Symptom - Erythema
    • Symptom - Hair loss
    • Symptom - Lesion
    • Specify - Wound

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

Beginning on August 18, 2016 and continuing twice daily until August 22, 2016 the owner gave the dog 3 loratadine 10 milligrams (mg) tablets. Also on August 18, 2016 the owner rinsed the dog's coat/skin (washed him off with a hose and also took him to the river daily). On August 19, 2016 the dog started rubbing the application site, and developed symptoms. On August 21, 2016 the owner gave the dog a percocet tablet 5 mg/325 mg. On August 22, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated the Zodiac product contains benzoyl peroxide. The APSS veterinarian additionally stated it can be irritating to the skin and mucous membranes, and allergic dermatitis can occur. The APSS veterinarian further stated concentrates that are applied to the skin could cause corrosive injury. The APSS veterinarian furthermore stated imidacloprid is an insecticidal agent that has a wide margin of safety in mammals as it kills insects by binding to the nicotinic acetylcholine receptors in the insect nervous tissue, which are much more prevalent than in mammals. The APSS veterinarian finally stated risks are for mild dermal irritation, usually more from the carriers than the ingredient itself. The APSS veterinarian stated regarding the loratadine tablet that loratadine is a long-acting tricyclic antihistamine with selective H1-receptor activity (second generation, or non-sedating antihistamine). The APSS veterinarian also stated risks at low doses (< 5-10 mg/kilogram (kg)), risks are for lethargy, vomiting, and ataxia. The APSS veterinarian additionally stated at doses above this, risks are for tachycardia, agitation, hyperactivity, mydriasis, possibly vocalization, hyperthermia, and hypertension. The APSS veterinarian further stated signs may persist for up to 48 hours. The APSS veterinarian furthermore stated therapeutic doses are up to 0.5 mg/kg. The APSS veterinarian finally stated low risks for tachycardia at this dose. The APSS veterinarian stated regarding the percocet, oxycodone is an opioid, used therapeutically in dogs at doses of 0.1-0.3 mg/kg by mouth (PO) every (q) 6-8 hours. The APSS veterinarian stated mild sedation may occur. The APSS veterinarian stated the acetaminophen (APAP) dose is not going to be a risk for liver toxicity, but there could be some risks for keratoconjunctivitis sicca (KCS). The APSS assistant recommended the owner not take the dog to the river with open wounds and to limit access to outdoors. The APSS assistant also recommended bathing the dog with liquid dish washing detergent (LDWD, Dawn) if the owner wanted to wash the dog. The APSS assistant additionally recommended if the owner wanted to give loratadine to give 2 tablets instead of 3 tablets, but noted that this was not going to help heal the pet. The APSS assistant recommended not giving Percocet to the dog. The APSS assistant recommended taking the dog to the veterinarian (concern for infection and the pet may need a steroid if he's itching and uncomfortable). The APSS assistant also recommended having the veterinarian call for information. The owner stated she wanted the company to pay for veterinarian (DVM) care. The APSS assistant recommended the owner contact the manufacturer (to discuss reimbursement for veterinary care).


To be determined by Registrant

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

Minor

19. Provide supplemental information here