Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4445

2. Registrant Information.

Registrant Reference Number: 080087695

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.

08-AUG-08

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

01-AUG-08

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. 2724-273

Product Name: Zodiac Fleatrol Flea Collar For Dogs With Necks Up To 20 Inches

• Active Ingredient(s)
  • CARBARYL
    • Guarantee/concentration 17 %

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-404-270

Product Name: Bio Spot Flea And Tick Spray For Dogs And Puppies

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

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7. b) Type of formulation.

Other (specify)

Collar

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 May 15, 2008 the owner applied the collar as a form of prevention. On June 15 and July 18, 2008, the owner applied the spray as a form of treatment. The last application was poured on dog and then rubbed into dog.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

American Pit Bull Terrier Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

30.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>2 mos <=6 mos / > 2 mois < = 6 mois

11. List all symptoms

System

• General
  • Symptom - Listless

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Grass ingestion

• Gastrointestinal System
  • Symptom - Weight loss

• Skin
  • Symptom - Hair loss
  • Specify - Excessive Shedding

• General
  • Symptom - Pale mucous membrane colour

• Renal System
  • Symptom - Renal failure

• Blood
  • Symptom - Blood urea nitrogen increased
  • Specify - Elevated Blood Urea Nitrogen

• Renal System
  • Symptom - Creatinine increased
  • Specify - Elevated Creatinine

• 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 August 8, the Animal Product Safety Service (APSS) veterinarian stated that these signs would not be expected with exposure to the products. The dog had also been exposed to a , chlorout product and pennies in the dog's water bowl. The APSS veterinarian recommended the owner take the dog to the veterinarian for an exam. Later that same day, the owner called back. He stated that he was on a limited budget and was unable to afford treatment. He purchased a vitamin supplement from a pet store and gave some to the dog. An APSS technician recommended again that the dog be seen by a veterinarian, and if treatment is not an option to have his veterinarian call us for recommendations. Later that day, the dog's veterinarian called to consult with an APSS veterinarian. The APSS veterinarian stated that these signs are not consistent with exposure to these products. The owner gave the dog B12 gel and obtained some metronidazole. On August 11, 2008 the owner called to say that they had taken the dog to an emergency veterinarian for bloodwork. The APSS veterinarian stated that according to the bloodwork results, the dog is in renal failure. This is a serious condition and the APSS veterinarian recommended the dog be hospitalized immediately. On August 12, 2008 the owner called to report that the dog was in the veterinary clinic on intravenous fluids. On August 18, 2008 the owner called to report that the dog's bloodwork is worsening, but that he did not have specific values. At this time they were considering euthanasia. On August 20, 2008, an APSS assistant called the clinic to obtain an update on the dog's condition, but was unable to obtain an update. On August 22, 2008, the dog's veterinarian called the APSS assistant and stated that the only time he had seen the patient was on August 7, 2008. The owner stated only that the dog had vomited a couple of times for a two to three days, was eating grass, and had a poor appetite. At that time the veterinarian diagnosed the dog with a sensitive trachea. He stated that he thought the dog was coughing from ingesting the grass and gagged to the point of vomiting. The veterinarian gave the dog an injection of Cerenia and sent the dog home on no medications. He stated that the last he had heard, the owners were obtaining several medications from local feed stores and trying to self-diagnose and treat at home. One of the owners called his office on August 18, 2008 and stated the dog was dead. The veterinarian stated that it was unlikely that the pet had been seen at another clinic to be euthanized, so it likely died at home.

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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

A follow up was not deemed necessary due to the inconsistencies in the case and the questionable reliability of the owner.