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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-4347

2. Registrant Information.

Registrant Reference Number: 150050718

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.

20-APR-15

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

16-APR-15

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 April 15, 2015 the owner bathed the dog with the shampoo for the first time.

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

Doberman Pinscher Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

63.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

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
  • General
    • Symptom - Lethargy
    • Symptom - Adipsia
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Drooling
  • General
    • Symptom - Hiding
    • Symptom - Polydipsia
  • Gastrointestinal System
    • Symptom - Bloody diarrhea
  • 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?

Yes

14. b) How long was the animal hospitalized?

1

Hour(s) / Heure(s)

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 April 16, 2015 the dog started vomiting, developed lethargy, adipsia, and anorexia. On April 17, 2015 the owner took the dog to the veterinarian, where radiographs were done (gas present), a chemistry profile, fluid therapy (subcutaneous), maropitant, metronidazole (250 milligrams twice daily), and an hour later the dog was discharged from the hospital. On April 18, 2015 the vomiting became more severe and the dog developed hypersalivation, polydipsia, and started hiding. On April 19, 2015 the dog developed bloody diarrhea and died several hours later. On April 20, 2015 the APSS veterinarian stated death is not expected.


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. A necropsy was not available.