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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0797

2. Registrant Information.

Registrant Reference Number: 130150270

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.

28-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

20-OCT-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. 2724-404

Product Name: Zodiac Fleatrol Flea And Tick Spray For Dogs Cats Puppies And Kittens

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .27 %
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .62 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .37 %
    • PYRETHRINS
      • Guarantee/concentration .2 %

7. b) Type of formulation.

Liquid

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 October 18, 2013 the owner sprayed the cat with the 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 )

0.92

7. Weight (provide a range if necessary )

2.3

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Difficulty walking
    • Specify - Dragging Rear Legs
    • Symptom - Disorientation
  • Blood
    • Symptom - Anemia
  • Nervous and Muscular Systems
    • Symptom - Collapse
  • Renal System
    • Symptom - Inappropriate urination
  • Gastrointestinal System
    • Symptom - Fecal incontinence
  • Respiratory System
    • Symptom - Mouth breathing
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Yes

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 October 20, 2013 the owner noticed that the cat was mildly anorexic and lethargic. At unknown times over the course of the rest of the cat's life, the lethargy became moderate and then severe. On October 21, 2013 the owner noticed that the cat was mildly ataxic. On October 22, 2013 the owner noticed that the cat was dragging his rear legs a bit. On October 23, 2013 the owner noticed that the cat's ataxia had become moderate and that the cat was disoriented. On October 25, 2013 the owner took that cat to the veterinarian, where the cat was observed to be mildly anemic, a corticosteroid and unknown Anthelmintic were given to the cat, and blood work revealed that the cat was negative for Feline Leukemia and Feline Immunodeficiency Virus (FIV). On October 26, 2013 the owner noticed that the cat's anorexia had worsened, his ataxia had become severe, and he dragging his rear legs more. On October 27, 2013 the owner noticed that the cat collapsed when the owner was feeding him a mixture of Pedialyte and chicken broth via syringe as a form of supportive care. That day the owner observed that the cat was also urinating inappropriately; this condition worsened at an unspecified time. That day the owner also noticed that the cat was experiencing fecal incontinence. In order to help keep the cat clean, the owner provided supportive care by washing him after he experienced urinary and fecal incontinence. On the morning of October 28, 2013 the owner noticed that the cat was breathing from his mouth. The owner went to work, but later that morning the owner called her father to check on the cat. At that time, the owner was informed that the cat had died. Later that day the owner contacted the Animal Product Safety Service (APSS) to obtain help. During the consultation the owner disconnected, and the APSS veterinarian called the owner back to continue to discuss the case. The APSS veterinarian stated that the main concern was for gastrointestinal (GI) upset and a taste reaction; with over-spraying, ataxia, depression, and lethargy could be seen, but these signs would be expected to occur on the same day as the product was applied. The APSS veterinarian also stated that the time frame and how the signs played out led her to believe that the cat's signs were not related to the use of the product. The APSS veterinarian recommended that the owner call back with questions. 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 causing the clinical situation.