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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-1459

2. Registrant Information.

Registrant Reference Number: 110007728

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.

18-JAN-11

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

17-JAN-11

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. 2724-759-270

Product Name: Adams D-Limonene Flea And Tick Shampoo For Dogs Cats Puppies Kittens

  • Active Ingredient(s)
    • D-LIMONENE

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 January 17, 2011, the owner bathed her dog with the product.

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

Dog / Chien

3. Breed

Pomeranian

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.2692

7. Weight (provide a range if necessary )

2.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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 January 17, 2011, after bathing the owner noticed the dog was symptomatic. On January 18, 2011, the owner contacted the Animal Product Safety Service (APSS) to obtain help. On January 18, 2011, the APSS veterinarian stated that severe signs were not expected. The APSS veterinarian further stated that she was concerned there might be some other reason for the signs the dog was exhibiting, such as parasitism or an infectious disease.


To be determined by Registrant

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

Death

19. Provide supplemental information here

On January 19, 2011, an APSS assistant contacted the owner to update the case. The owner stated her dog was still vomiting and that per her regular veterinarian's advice she had been giving her dog Pedialyte and sugar. The APSS veterinarian also recommended bathing the dog with liquid dishwashing detergent (LWLD) and taking the dog to the veterinarian if the dog's condition did not improve. The APSS veterinarian also recommended the owner offer food to try to get the dog to eat and advised the owner to call back with questions. On January 21, 2011, the APSS veterinarian called the owner to update the case and the owner stated her dog had died on January 19, 2011 and had already been buried, so a necropsy was not available.