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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6441

2. Registrant Information.

Registrant Reference Number: 130094169

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.

09-JUL-13

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

02-JUL-13

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. 2724-504-270

Product Name: Adams Spot On Flea And Tick Control For Cats And Kittens Under 5 Lbs

  • Active Ingredient(s)
    • ETOFENPROX
      • Guarantee/concentration 40 %
    • (S)-METHOPRENE
      • Guarantee/concentration 3,6 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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 July 1, 2013 the owner applied the product to 5 of her kittens.

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

Female

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

4.00

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Eye
    • Symptom - Discharge eye
  • Respiratory System
    • Symptom - Sneezing
  • General
    • Symptom - Other
    • Specify - Odor
    • 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 July 2, 2103 the owner noticed that the kitten was symptomatic. On July 3, 2013 the owner observed that the kitten had died. On July 9, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that no significant signs would be expected. The APSS veterinarian referred the owner to the product's manufacturer to discuss a refund. A necropsy was not available.


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 the clinical situation. A follow up was not performed, because additional information was not expected. Owner was unwilling to bring cat in for medical treatment and have never received vaccines/medical care.

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

Female

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

4.50

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Eye
    • Symptom - Discharge eye
  • Respiratory System
    • Symptom - Sneezing
  • General
    • Symptom - Other
    • Specify - Odor
    • 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 July 2, 2103 the owner noticed that the kitten was symptomatic. On July 3, 2013 the owner observed that the kitten had died. On July 9, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that no significant signs would be expected. The APSS veterinarian referred the owner to the product's manufacturer to discuss a refund. A necropsy was not available.


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 the clinical situation. A follow up was not performed, because additional information was not expected. Owner was unwilling to bring cat in for medical treatment and have never received vaccines/medical care.

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

Female

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

3.50

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Eye
    • Symptom - Discharge eye
  • Respiratory System
    • Symptom - Sneezing
  • General
    • Symptom - Other
    • Specify - Odor
    • 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 July 2, 2103 the owner noticed that the kitten was symptomatic. On July 3, 2013 the owner observed that the kitten had died. On July 9, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that no significant signs would be expected. The APSS veterinarian referred the owner to the product's manufacturer to discuss a refund. A necropsy was not available.


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 the clinical situation. A follow up was not performed, because additional information was not expected. Owner was unwilling to bring cat in for medical treatment and have never received vaccines/medical care.

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 )

0.25

7. Weight (provide a range if necessary )

4.00

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Eye
    • Symptom - Discharge eye
  • Respiratory System
    • Symptom - Sneezing
  • General
    • Symptom - Other
    • Specify - Odor
    • 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 July 2, 2103 the owner noticed that the kitten was symptomatic. On July 3, 2013 the owner observed that the kitten had died. On July 9, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that no significant signs would be expected. The APSS veterinarian referred the owner to the product's manufacturer to discuss a refund. A necropsy was not available.


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 the clinical situation. A follow up was not performed, because additional information was not expected. Owner was unwilling to bring cat in for medical treatment and have never received vaccines/medical care.

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 )

0.33

7. Weight (provide a range if necessary )

4.00

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Renal System
    • Symptom - Urinary incontinence
  • Nervous and Muscular Systems
    • Symptom - Disorientation
  • 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 July 8, 2013 the owner noticed that the cat was symptomatic. On July 10, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian also stated that no significant signs would be expected. The APSS assistant recommended that the owner take the cat to her regular veterinarian, have her regular veterinarian call for information, and call back with questions. The owner disconnected, and the APSS assistant called the owner back immediately to continue to discuss the case. The owner stated that the kitten had just died. The APSS veterinarian recommended that the owner have a necropsy done the following morning and keep the kitten's body in the refrigerator overnight. The APSS veterinarian then recommended that the owner have her regular veterinarian call for information on the necropsy.


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 the clinical situation. A follow up was not performed, because additional information was not expected. Owner was unwilling to bring cat in for medical treatment and have never received vaccines/medical care.