Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-3101

2. Registrant Information.

Registrant Reference Number: 160007089

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.

15-JAN-16

5. Location of incident.

Country: UNITED STATES

Prov / State: WASHINGTON

6. Date incident was first observed.

15-JAN-14

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-815

Product Name: Kirkland Signature Flea And Tick Control For Medium Dogs 13-31 Lbs

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 3.6 %
  • ETOFENPROX
    • Guarantee/concentration 30 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 5 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

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 January 15, 2014 the owner applied the product onto both dogs of unknown weight as prevention.

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

Dachshund Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Skin
  • Symptom - Hair loss

• Gastrointestinal System
  • Symptom - Anorexia

• Liver
  • Symptom - Hepatic failure

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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 January 15, 2014 the dog developed alopecia and anorexia. On April 15, 2014 the dog died and the dog's regular veterinarian said the dog had acute hepatic failure. At the time, blood work and a necropsy could not be performed due to finances. On January 15, 2016 the owner was going to use the product on the dogs he has now and the owner's regular veterinarian told him not to, as the product caused the liver failure in the previous dogs. So the owner contacted the Animal Product Safety Service (APSS) to report the deaths. The APSS veterinarian stated etofenprox is in the pyrethroid family, and is safe to use on cats and dogs and it does not result in tremors or seizure activity that can be seen from other pyrethroids, since it is structurally different. The APSS veterinarian also stated dermal exposures may cause mild dermal irritation and hyperesthesia within the first 24-48 hours, and possibly secondary alopecia from pruritus. The APSS veterinarian additionally stated oral exposures often result in hypersalivation, nausea, and possibly hiding because of the taste and some animals will hypersalivate just from the odor of the product. The APSS veterinarian further stated s-methoprene is an insect growth regulator (IGR) and primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers, and if ingested there could be hypersalivation and nausea. The APSS veterinarian finally stated piperonyl butoxide is a synergist to enhance the efficacy of the ingredients.

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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 not considered to be related to causing the clinical situation. The APSS technician provided the manufacturer's contact information as the owner stated he wanted the product taken off the market.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Dachshund Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Skin
  • Symptom - Hair loss

• Gastrointestinal System
  • Symptom - Anorexia

• Liver
  • Symptom - Hepatic failure

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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 January 15, 2014 the dog developed alopecia and anorexia. On April 15, 2014 the dog died and the dog's regular veterinarian said the dog had acute hepatic failure. At the time, blood work and a necropsy could not be performed due to finances. On January 15, 2016 the owner was going to use the product on the dogs he has now and the owner's regular veterinarian told him not to, as the product caused the liver failure in the previous dogs. So the owner contacted the Animal Product Safety Service (APSS) to report the deaths. The APSS veterinarian stated etofenprox is in the pyrethroid family, and is safe to use on cats and dogs and it does not result in tremors or seizure activity that can be seen from other pyrethroids, since it is structurally different. The APSS veterinarian also stated dermal exposures may cause mild dermal irritation and hyperesthesia within the first 24-48 hours, and possibly secondary alopecia from pruritus. The APSS veterinarian additionally stated oral exposures often result in hypersalivation, nausea, and possibly hiding because of the taste and some animals will hypersalivate just from the odor of the product. The APSS veterinarian further stated s-methoprene is an insect growth regulator (IGR) and primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers, and if ingested there could be hypersalivation and nausea. The APSS veterinarian finally stated piperonyl butoxide is a synergist to enhance the efficacy of the ingredients.

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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 not considered to be related to causing the clinical situation. The APSS technician provided the manufacturer's contact information as the owner stated he wanted the product taken off the market.