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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0862

2. Registrant Information.

Registrant Reference Number: 100157893

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-DEC-10

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

6. Date incident was first observed.

01-NOV-10

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. 2724-497-270

Product Name: Bio Spot Spot On Flea And Tick Control For Dogs Under 15lbs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3 %
    • PERMETHRIN
      • Guarantee/concentration 45 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.034

Units: oz (fl) / oz (liquide)

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 November 1, 2010 and December 1, 2010 the owner applied the product to the dog as prevention.

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

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

6

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Subdued
    • Symptom - Pain
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Depression
  • General
    • Symptom - Edema
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
  • Respiratory System
    • Symptom - Difficulty Breathing
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
  • Gastrointestinal System
    • Symptom - Constipation
  • Liver
    • Symptom - Hepatomegaly
  • Cardiovascular System
    • Symptom - Heart murmur
  • Gastrointestinal System
    • Symptom - Constipation
    • Specify - Absent Bowel Movements
    • Symptom - Abdominal distension
  • 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 November 1, 2010 the owner noticed the dog was symptomatic. All signs resolved on November 16, 2010. On December 1, 2010 the owner noticed the dog was again subdued, painful, was vocalizing, and depressed. On December 9, 2010 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated some animals will exhibit abnormal behavior in response to the skin sensation caused by dermal application. The APSS veterinarian recommended the owner should monitor the dog at home, bathe the dog twice with liquid dish washing detergent, apply cold compresses and vitamin E oil o the application site, and look into alternative flea products with different active ingredients. On December 13, 2010 the dog was anorexic, adipsic, having respiratory difficulty, was constipated, and had difficulty walking. On the same day, the attending veterinarian radiographed the dog, as well as administered methocarbamol, metronidazole, and Gastrocoat. The dog was diagnosed with hepatomegaly and a heart murmur. On December 16, 2010 the attending veterinarian gave the dog an enema and administered metoclopramide after noting the dog had absent bowel movements and a distended abdomen. On December 21, 2010 the dog died. The same day the attending veterinarian called the APSS. The APSS veterinarian recommended a necropsy.


To be determined by Registrant

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

Death

19. Provide supplemental information here

According to the gross necropsy, a presumptive diagnosis of hypertrophic cardiomyopathy was made but histopathology is still pending.