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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7281

2. Registrant Information.

Registrant Reference Number: 130134260

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.

24-SEP-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

23-SEP-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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea And Tick Control For Dogs Under 14 kg

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PERMETHRIN

7. b) Type of formulation.

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 September 22, 2013 the owner inappropriately applied the dog product to 2 cats to treat for fleas.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

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 )

8.0

7. Weight (provide a range if necessary )

15.0

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

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Fasciculations

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 September 23, 2013 the owner noticed that the cat was symptomatic. On September 24, 2013 the owner took the cat to the veterinarian, where the cat was bathed with aloe and oatmeal shampoo. Later that morning the owner's veterinary staff contacted the Animal Product Safety Service (APSS) to obtain help; during the consultation the veterinary staff gave the cat fluid therapy subcutaneously. The APSS veterinarian stated that concentrated permethrins and pyrethroids can be highly toxic in cats and that the risk is for ataxia, tremors, agitation, facial and ear twitching, seizures, hyperthermia, and potentially death if untreated. The APSS veterinarian stated that with prompt treatment there is a good prognosis and signs may persist for 24 to 72 hours. The APSS veterinarian recommended that the owner's veterinary staff give the cat 61 to 132 milligrams per kilogram (mg/kg) of Methocarbamol each day, divided into twice-daily to thrice-daily doses over 5 days; apply vitamin E topically at the application site; apply a cold compress to the application site; give the cat 2 mg/kg of Diphenhydramine by mouth or subcutaneously; and call back with questions.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Extra Label Use: Owner inappropriately applied dog product to cat. Not labelled for use on cats

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

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 )

8.0

7. Weight (provide a range if necessary )

16.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Fasciculations

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 September 25, 2013 the owner noticed that the cat was having fasciculations. On September 26, 2013 the owner's veterinary staff contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that concentrated permethrins and pyrethroids can be highly toxic in cats and that the risk is for ataxia, tremors, agitation, facial and ear twitching, seizures, hyperthermia, and potentially death if untreated. The APSS veterinarian stated that with prompt treatment there is a good prognosis and signs may persist for 24 to 72 hours. The APSS veterinarian recommended that the owner's veterinary staff bathe the cat, apply vitamin E to the application site, and give Methocarbamol orally. The APSS veterinarian also discussed the kinetics of the agent and informed the veterinary staff that residual mild twitching could occur for 5 days.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Extra Label Use: Owner inappropriately applied dog product to cat. Not labelled for use on cats.