Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-2030

2. Registrant Information.

Registrant Reference Number: 120015377

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.

07-FEB-12

5. Location of incident.

Country: UNITED STATES

Prov / State: ALABAMA

6. Date incident was first observed.

05-FEB-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-485-270

Product Name: Farnam Bio Spot Shampoo For Dogs And Puppies

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .1 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 1.5 %
  • PYRETHRINS
    • Guarantee/concentration .15 %

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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 February 4, 2012 the owner bathed the dog with the shampoo product to treat for fleas.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Toy Fox Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10.0

7. Weight (provide a range if necessary )

11.0

lbs

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

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

11. List all symptoms

System

• General
  • Symptom - Death

• Cardiovascular System
  • Symptom - Other
  • Specify - multifocal endocardiosis in the left atrioventricular valve
  • Symptom - Other
  • Specify - presumptive moderate

• Liver
  • Symptom - Other
  • Specify - diffuse hepatic congestion in the liver

• Renal System
  • Symptom - Other
  • Specify - presumptive nephropathy in the left kidney.

• Cardiovascular System
  • Symptom - Other
  • Specify - mild multifocal interstitial fibrosis with myofiber hypertrophy and rare degeneration and loss
  • Symptom - Other
  • Specify - the endocardium (left atrioventricular valve) revealed moderate chronic diffuse endocardiosis;

• Renal System
  • Symptom - Other

12. How long did the symptoms last?

Unknown / Inconnu

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 the evening of February 5, 2012 the owner came home and discovered that the dog had died. On February 6, 2012 the owner took the dog's body to the veterinarian and a necropsy was performed. On February 7, 2012 the owner's regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the ingredients in the shampoo product have a wide margin of safety in dogs and that significant signs would not be expected after product use. The owner's regular veterinarian reported that she did not observe anything abnormal on the gross necropsy and that the histopathology had not been sent out. The APSS technician recommended additional necropsy testing.

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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. On February 8, 2012 an APSS technician called the regular veterinarian to discuss the necropsy and faxed instructions and the submission form to the clinic. On February 13, 2012 an APSS technician called the diagnostic laboratory to update the case and discuss additional toxicology testing. The diagnostic laboratory stated that the pet's body had been received on February 10, 2012. On February 14, 2012 the interim necropsy results were received. The results revealed presumptive moderate, multifocal endocardiosis in the left atrioventricular valve; presumptive moderate, diffuse hepatic congestion in the liver; and presumptive nephropathy in the left kidney. Due to the initial necropsy performed by the regular veterinarian and the freezing and subsequent thawing of the carcass, the condition of the carcass did not allow for adequate assessment of all tissues, and thus the cause of the dog's death was not apparent upon gross examination. The observed presumptive left atrioventricular valve endocardiosis could be suggestive of a cardiac pathology. Appropriate samples have been taken for histopathology, although the advanced state of autolysis could hinder adequate histological evaluation of the tissue specimens. In addition, samples of the eye, brain, liver, kidney, fat, and skin were taken for toxicology and are currently being held. On February 16, 2012 a second set of interim necropsy results with the histopath report was received. The heart revealed mild multifocal interstitial fibrosis with myofiber hypertrophy and rare degeneration and loss; the endocardium (left atrioventricular valve) revealed moderate chronic diffuse endocardiosis; the liver revealed mild random necrotizing hepatitis; the spleen revealed moderate hemosiderosis; the duodenum revealed minimal multifocal crypt abscess formation; and the kidney revealed mild, diffuse, segmental membranous glomerulonephritis with mild multifocal interstitial fibrosis. Adequate evaluation was hindered because the patient was presented with severe post-mortem autolysis. Although a definitive cause of death was not observed, the observed cardiac and endocardial pathology could be suggestive of a cardiac arrhythmia as a potential cause of death. There was also mild random necrotizing hepatitis, but the extent of the lesion does not suggest clinical significance. The exact etiology of the necrotizing hepatitis could not be established, but bacterial pathogens could be considered. The widespread hepatic and splenic hemosiderosis suggests increased red blood cell destruction or turnover due to an unknown reason. The renal lesions are most likely related to the patient's age. The brain, liver, and skin were sent to another laboratory to rule out toxicity. GCMS toxicant screen of brain, liver, and skin were negative for toxic organic compounds.