Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-5599

2. Registrant Information.

Registrant Reference Number: 140098514

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-AUG-14

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

05-AUG-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. 2724-813-270

Product Name: Adams Flea and Tick Spot On for Cats and Kittens 5 Lbs and Over Refill

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 3.6 %
  • ETOFENPROX
    • Guarantee/concentration 40 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.8

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 5, 2014 the owner applied the product onto 25 of her cats.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

2

5. Sex

Male

Female

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

5.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Drooling

• Skin
  • Symptom -
  • Specify - Greasy Hair Coat

• Nervous and Muscular Systems
  • Symptom - Recumbent

• 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 August 5, 2014 one of the cats developed symptoms and died a short time after. On August 6, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated methoprene is an insect growth regulator (IGR) and primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers. The APSS veterinarian also stated if ingested there could be hypersalivation and nausea. The APSS veterinarian further stated etofenprox is in the pyrethroid family, and is safe to use on cats and dogs. The APSS veterinarian also stated it does not result in tremors or seizure activity that can be seen from other pyrethroids, since it is structurally different. The APSS veterinarian further stated oral exposures often result in hypersalivation, nausea, and possibly hiding because of the taste. The APSS veterinarian finally stated some animals will hypersalivate just from the odor of the product. The APSS veterinarian recommended a necropsy, which the owner declined.

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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 considered to have a doubtful likelihood of causing the clinical situation.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

6

5. Sex

Male

Female

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

7.5

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

• 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 August 6, 2014 six of the cats died, so the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated methoprene is an insect growth regulator (IGR) and primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers. The APSS veterinarian further stated etofenprox is in the pyrethroid family, and is safe to use on cats and dogs. The APSS veterinarian also stated it does not result in tremors or seizure activity that can be seen from other pyrethroids, since it is structurally different. The APSS veterinarian recommended a necropsy, which the owner declined.

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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 considered to have a doubtful likelihood of causing the clinical situation.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

2

5. Sex

Male

Female

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

7.5

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

• Gastrointestinal System
  • Symptom - Drooling

• Nervous and Muscular Systems
  • Symptom - Recumbent

• Skin
  • Symptom - Other
  • Specify - Greasy Hair Coat

• 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 August 6, 2014 both cats developed symptoms and died a short time after. On August 6, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated methoprene is an insect growth regulator (IGR) and primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers. The APSS veterinarian also stated if ingested there could be hypersalivation and nausea. The APSS veterinarian further stated etofenprox is in the pyrethroid family, and is safe to use on cats and dogs. The APSS veterinarian also stated it does not result in tremors or seizure activity that can be seen from other pyrethroids, since it is structurally different. The APSS veterinarian stated oral exposures often result in hypersalivation, nausea, and possibly hiding because of the taste. The APSS veterinarian finally stated some animals will hypersalivate just from the odor of the product. The APSS veterinarian recommended a necropsy, which the owner declined.

---

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 considered to have a doubtful likelihood of causing the clinical situation.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

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 )

7.5

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 - Other
  • Specify - Greasy Hair Coat

• 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 August 6, 2014 the cat developed a greasy hair coat and died a few hours after. On August 6, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated methoprene is an insect growth regulator (IGR) and primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers. The APSS veterinarian further stated etofenprox is in the pyrethroid family, and is safe to use on cats and dogs. The APSS veterinarian also stated it does not result in tremors or seizure activity that can be seen from other pyrethroids, since it is structurally different. The The APSS veterinarian recommended a necropsy, which the owner declined.

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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 considered to have a doubtful likelihood of causing the clinical situation.