Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-3409

2. Registrant Information.

Registrant Reference Number: 140080537

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.

30-JUN-14

5. Location of incident.

Country: UNITED STATES

Prov / State: ALABAMA

6. Date incident was first observed.

30-JUN-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 June 30, 2014 the owner applied the product on his two 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 Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

8.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Drooling
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Fasciculations

• 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 June 30, 2014 immediately after the product was applied, the cat became symptomatic. The owner then bathed the cat with baby shampoo. Later that day, the owner contacted the Animal Product Safety Service (APSS) and stated the cat had died. The owner disconnected while on hold, so the APSS technician called the owner back. The owner stated he was taking the cats to the veterinary clinic and declined to talk the APSS veterinarian. The APSS veterinarian stated contact hypersensitivity may occur as with any topical exposure. The APSS veterinarian also stated in addition, some animals exhibit abnormal behavior in response to the dermal sensation (paresthesia) that may be associated with this type of product. The APSS veterinarian finally stated if ingested, gastrointestinal (GI) upset and/or a taste reaction may occur. The APSS technician recommended the owner have the veterinarian call for information.

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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. On June 30, 2014 the APSS veterinarian called the owner due to the death. A necropsy was not available.

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 )

13.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Drooling
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Fasciculations

• 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 June 30, 2014 immediately after the product was applied, the cat became symptomatic. The owner then bathed the cat with baby shampoo. Later that day, the owner contacted the Animal Product Safety Service (APSS) and stated the cat had died. The owner disconnected while on hold, so the APSS technician called the owner back. The owner stated he was taking the cats to the veterinary clinic and declined to talk the APSS veterinarian. The APSS veterinarian stated contact hypersensitivity may occur as with any topical exposure. The APSS veterinarian also stated in addition, some animals exhibit abnormal behavior in response to the dermal sensation (paresthesia) that may be associated with this type of product. The APSS veterinarian finally stated if ingested, gastrointestinal (GI) upset and/or a taste reaction may occur. The APSS technician recommended the owner have the veterinarian call for information.

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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. On June 30, 2014 the APSS veterinarian called the owner due to the death. A necropsy was not available.