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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0850

2. Registrant Information.

Registrant Reference Number: 100136681

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.

21-OCT-10

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

21-OCT-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. 2724-796-270

Product Name: Adams Flea and Tick Spot On E30 for Small Dogs 5-15 Lbs

  • Active Ingredient(s)
    • ETOFENPROX
      • Guarantee/concentration 30 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 5 %
    • (S)-METHOPRENE
      • Guarantee/concentration 3,6 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1,5

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 October 20, 2010 the owner applied the product onto the under labelled aged puppy.

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

Parson Russell Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.1346

7. Weight (provide a range if necessary )

6

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
  • General
    • Symptom - Lethargy
    • 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 21, 2010 the puppy became symptomatic, so the owner bathed the puppy with liquid dish washing detergent. Then owner then contacted the Animal Product Safety Service (APSS). TThe APSS veterinarian stated tremors are unlikely even given the extra label use of the product. The APSS assistant relayed the APSS veterinarian's recommendations to give the puppy nothing by mouth, manage the puppy's vomiting, monitor the puppy's mucous membrane color, provide the puppy with Karo syrup, give the puppy a bland diet, take the puppy to the veterinarian if the signs persist in the next hour, have the veterinarian call for information, and call back with questions.


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. On October 27, 2010 an APSS assistant called the owner to follow up the case. The owner stated that the puppy had tested positive for parvovirus and had died on October 21, after the APSS consultation. This product was not used according to label directions: do not use on dogs less than 6 months of age.