Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-3863

2. Registrant Information.

Registrant Reference Number: 180074324

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.

03-MAY-18

5. Location of incident.

Country: UNITED STATES

Prov / State: LOUISIANA

6. Date incident was first observed.

01-MAY-18

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. 2724-829-89459

Product Name: Bio Spot Active Care Flea And Tick Spot On For Dogs 61-150 Lbs

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .23 %
  • ETOFENPROX
    • Guarantee/concentration 50 %
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration .91 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .45 %

---

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

7.3

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 April 30, 2018 the owner applied the product to the dog as prevention.

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

German Shepherd

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 )

75.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Abnormal behaviour
  • Specify - Behavioral Change

• Nervous and Muscular Systems
  • Symptom - Depression

• General
  • Symptom - Pale mucous membrane colour

• Nervous and Muscular Systems
  • Symptom - Collapse

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

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 May 1, 2018 the dog experienced a behavioral change in the morning and that afternoon, the dog developed depression, pale mucous membrane color, vomiting (clear liquid), and collapsed. Soon after, the owner bathed the dog five times with Dawn dish soap. After the bath, the dog seemed improved and her symptoms became mild. In the afternoon on May 2, 2018, the dog passed away. At an unknown time, the owner contacted their regular veterinarian who recommended a necropsy but the dog had already been buried. On May 3, 2018, the owner contacted the Animal Product Safety Service (APSS) whose assistant stated that death would not be expected from this product. The APSS assistant stated that although etofenprox is in the pyrethroid family, it is structurally different and safe to use on dogs and it does not result in tremors or seizure activity that can be seen from other pyrethroids. The APSS assistant stated that oral exposures often result in hypersalivation, nausea, and possibly hiding because of the taste and that some animals will hypersalivate just from the odor of the product. The APSS assistant also stated that pyriproxyfen is an insect growth regulator (IGR) that disrupts the reproductive cycles of fleas and it also has low mammalian toxicity and that (S)-methoprene is an IGR and that if ingested, there could be hypersalivation and nausea. Finally, the APSS assistant stated that piperonyl butoxide and MGK-264 are synergists to enhance the efficacy of the ingredients. The APSS assistant recommended referral of the owner to the manufacturer and to call back with questions.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS assistant stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. In the afternoon on May 3, 2018, the owner contacted the APSS to continue the case. The APSS veterinarian explained that these signs would not have been expected from this product and transferred the owner to the manufacturer.