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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-1427

2. Registrant Information.

Registrant Reference Number: 150147846

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.

25-OCT-15

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

25-OCT-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. 1021-2684-89459

Product Name: Adams Flea And Tick Dip For Dogs And Cats

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 3 %
    • PYRETHRINS
      • Guarantee/concentration .3 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

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 October 25, 2015 the owner used the product on the dog (diluted 4 ounces (oz) in 1 gallon of water per label).

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

Cocker Spaniel

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Collapse
  • General
    • 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 October 25, 2015 the dog collapsed, so the owner bathed the dog (using Dawn). Shortly after the dog died. Later that evening, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian provided information that death is not expected, so more answers would be needed. The APSS veterinarian recommended a necropsy, having the veterinarian call for information, and calling 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 26, 2015 the owner called back to discuss payment for the necropsy and her concerns for sending the dog's body out. The APSS assistant recommended the attending veterinarian call the APSS to discuss the details. On October 26, 2015 the attending veterinary technician called the APSS to discuss the necropsy. Later that morning the owner called the APSS to request a copy of the necropsy findings. Shortly after the attending veterinarian called the APSS to state that she did convince the owner to submit the whole body and questioned what type of necropsy would be done. The APSS veterinarian stated that the gross necropsy findings would be sent to the APSS and to the clinic and the histo results usually take a few weeks to receive. On October 29, 2015 the APSS received the interim report. The morphologic diagnosis showed the body as a whole showed icterus and anemia; the skin showed ectoparasitism (marked flea infestation), hyperkeratosis (multifocal), and claw (overgrowth); the spleen showed splenic nodules; the testis showed testicular tumor (left and right); the prostrate showed moderate prostatomegaly; and the bone marrow was reactive. On November 5, 2015 the final necropsy results were received. The brain showed intracytoplasmic eosinophil inclusion bodies and neuronal cell bodies; the liver showed centrilobular necrosis; the liver showed portal bridging fibrosis; the liver showed vacuolar hepatopathy; the bone marrow showed myeloid and erythroid hyperplasia; the spleen showed extramedullary hematopoiesis; the kidney showed renal tubular proteinosis and hypertrophy; the lungs showed smooth muscle hypertrophy and anthracosis; the testis showed sertoli cell turmor; and the skin showed hepatoid gland hypertrophy. Postmortem findings are supportive of this animal being anemic as not a large amount of blood was observed at necropsy examination. Histologically there is centrilobular hepatic necrosis consistent with hypoxia/anemia, extramedullary hematopoiesis within the spleen and reactive diaphyseal bone marrow. Large numbers of fleas are identified on this dog which would explain the suspected anemia. This dog has gross evidence of icterus and testing for infectious agents such as Anaplasma spp. and Ehrlichia spp. can be performed for an additional fee. The severe anemia is considered to have most likely caused the death of this animal. Numerous inclusion bodes are identified with neuronal cell bodies and Purkinje cells within the brain. Immunohistchemical staining of the brain for rabies virus and canine distemper virus are negative. The inclusions are consistent with Rabies-like inclusion bodies. Within the kidneys there is hypertrophy of the epithelium lining distal convoluted tubules. A cause for this is not known. No further tests are pending. The APSS veterinarian stated that anemia was considered to have a high likelihood of causing the clinical situation. On November 7, 2015 the APSS veterinarian made an attempt to call the owner to discuss the necropsy results. On November 9, 2015 the APSS veterinarian called the attending veterinary clinic to discuss the necropsy results. The attending veterinarian stated they had received the results and did not have further questions. Shortly after the APSS veterinarian called the owner to discuss the necropsy results and left a message stating her veterinary clinic had a copy of the results and how to reach the APSS if she had any questions.