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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1011

2. Registrant Information.

Registrant Reference Number: 120111710

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.

10-AUG-12

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

6. Date incident was first observed.

09-AUG-12

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

  • 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 August 9, 2012 the owner bathed the 2 puppies to treat for fleas.

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 )

0.25

7. Weight (provide a range if necessary )

Unknown

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

  • 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.

No

14. a) Was the animal hospitalized?

No

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 9, 2012 the owner applied the product to the puppy. Later that evening, the owner noticed that the puppy was lethargic. The owner noticed that later that evening the dog had died while unattended. On August 10, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that severe signs would not be expected following the label use of the product. A necropsy was not available because the body had not been stored properly after death.


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 considered to have a doubtful likelihood of causing the clinical situation.

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

Male

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Unresponsive
  • General
    • Symptom - Pale mucous membrane colour
    • Symptom - Vocalizing
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

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 9, 2012 the owner noticed that the dog was moderately lethargic. On August 10, 2012 the owner observed that the dog's lethargy had become severe and he was unresponsive. Later that morning, the owner called her regular veterinarian, who was planning to come to the owner's house to assess the case. A short time later, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that sever signs are not expected. The APSS veterinarian also stated that more severe signs would not be expected following the label use of the shampoo product. During the consultation with the APSS, the owner noted that the dog's mucous membranes were pale. The APSS veterinarian recommended that the owner put Karo syrup or another sugary substance on the dog's mucous membranes; the owner said that she had frosting at home.


To be determined by Registrant

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

Death

19. Provide supplemental information here

On August 11, 2012 the owner called the APSS to update the case. The owner stated that on August 10, 2012 after consulting with the APSS, she put a sugary substance on the dog's mucous membranes. The owner also stated that the dog died on August 11, 2012. The APSS veterinarian recommended that the owner have her veterinarian call for information regarding a necropsy and to keep the dog's body chilled in the refrigerator so that a necropsy could be performed. On August 13, 2012 the owner's veterinary clinic called the APSS to discuss a necropsy. After several contacts with the clinic, on August 15, 2012 the body was picked up for the necropsy. On August 16, 2012 interim necropsy results were received. The interim results revealed a minimal nematode infection in the dog's small intestine. The histopathology results are pending and fresh tissue samples were saved in case ancillary testing was required. On August 21, 2012 final necropsy results were received. The results revealed no significant gross or histologic findings, and the head and brain were not available for examination. Based on the lack of significant findings, it is likely that an infectious etiology was not the cause of death; at this point, metabolic abnormalities such as hypoglycemia and potential D-Limonene toxicity remain possible differentials for the dog's death.