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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2013-5546

2. Registrant Information.

Registrant Reference Number: 130109516

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-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

25-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. 26413      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Double Action Flea And Tick Shampoo For Dogs And Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 24, 2013 the owner applied a spot on product to 3 cats to treat for fleas. On July 31, 2013 the owner bathed the 3 cats with the shampoo product to treat for fleas.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8.0

7. Weight (provide a range if necessary )

4.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Depression

12. How long did the symptoms last?

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

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

Unknown/Inconnu

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 24, 2013 the owner had applied a spot on product to treat a pre-existing flea infestation that led to the cat's pruritus. On July 31, 2013 the owner bathed the cat with the shampoo product to try to treat the flea infestation. A couple of hours later the owner noticed that the cat was symptomatic. On August 1, 2013 the owner noticed that the cat was no longer symptomatic; however, the cat was still experiencing the pre-existing pruritus. On August 6, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the risk with both products the cat had been exposed to was for dermal sensitivity. The APSS veterinarian recommended that the owner monitor the cat at home for dermatological signs and call back with questions.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

On August 7, 2013 the owner contacted the APSS to ask if she could be compensated for possible diagnostics for the cat, and the APSS veterinarian informed her that she wasn't sure, but the cat's signs were not consistent with the use of the product. The APSS veterinarian stated that the owner might want to call the product's manufacturer regarding this matter. The owner did not state how the cat was doing, so the outcome of this case is unknown. Though they were not able to pinpoint the exact cause of death the necropsy results indicated the presence of an upper respiratory infection and kidney disease. Status update: Added Notes in field 19 - updated Necropsy results

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 )

8.0

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

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

11. List all symptoms

System

  • General
    • Symptom - Loss of voice
    • Specify - Dysphonia

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown/Inconnu

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 24, 2013 the owner had applied a spot on product to treat a pre-existing flea infestation that led to the cat's pruritus. On July 31, 2013 the owner bathed the cat with the shampoo product to try to treat the flea infestation. On August 6, 2013 the owner observed that the cat was dysphonic. Later that evening the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the risk with both products the cat had been exposed to was for dermal sensitivity. The APSS veterinarian recommended that the owner monitor the cat at home for dermatological signs and call back with questions.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

The APSS veterinarian stated that the shampoo product was considered to have a doubtful likelihood of causing the clinical situation. On August 7, 2013 the owner contacted the APSS to ask if she could be compensated for possible diagnostics for the cat, and the APSS veterinarian informed her that she wasn't sure, but the cat's signs were not consistent with the use of the product. The APSS veterinarian stated that the owner might want to call the product's manufacturer regarding this matter. The owner did not state how the cat was doing, so the outcome of this case is unknown. Though they were not able to pinpoint the exact cause of death the necropsy results indicated the presence of an upper respiratory infection and kidney disease. Status update: Added Notes in field 19 - updated Necropsy results

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

Female

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

2.0

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

  • General
    • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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 July 24, 2013 the owner had applied a spot on product to treat a pre-existing flea infestation that led to the cat's pruritus. On July 25, 2013 the owner noticed that the cat was ataxic; the cat was no longer ataxic on July 27, 2013, but the cat's pre-existing pruritus remained. On July 31, 2013 the owner bathed the cat with the shampoo product to try to treat the flea infestation. On August 6, 2013 the owner observed that the cat had died. A short time later that evening the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the risk with both products the cat had been exposed to was for dermal sensitivity. The APSS veterinarian recommended that the owner have a necropsy done to determine the cause of the cat's death.


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 shampoo product was considered to have a doubtful likelihood of causing the clinical situation. Later on the evening of August 6, 2013 the owner contacted the APSS to provide the number of the veterinary clinic where she would take the body so that a necropsy could be done. On August 7, 2013 an APSS veterinarian contacted the owner's regular veterinarian to discuss the necropsy; the APSS veterinarian sent the necessary forms to the clinic. Later that morning the owner's regular veterinary staff informed the APSS that the animal would be submitted for necropsy that day. Though they were not able to pinpoint the exact cause of death the necropsy results indicated the presence of an upper respiratory infection and kidney disease. Status update: Added Notes in field 19 - updated Necropsy results