Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1021

2. Registrant Information.

Registrant Reference Number: 120107009

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.

01-AUG-12

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

Unknown

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. 25582      PMRA Submission No.       EPA Registration No.

Product Name: Vet Kem Siphotrol 2000 Double Action Premise Treatment

• Active Ingredient(s)
  • (S)-METHOPRENE
  • PERMETHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - In Home / Rés. - à l'int. maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

The owner sprayed the product inside the home for a week, and sometime between July 25 and July 27, 2012 the dog was accidentally exposed to the product by an unknown route.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Miniature Poodle

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

16.5

7. Weight (provide a range if necessary )

12.0

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Paralysis
  • Symptom - Ataxia

• General
  • Symptom - Licking

• Gastrointestinal System
  • Symptom - Fecal incontinence

• Liver
  • Symptom - Elevated liver enzymes
  • Specify - elevated serum liver enzymes

12. How long did the symptoms last?

Unknown / Inconnu

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?

Unknown

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On August 1, 2012 the dog had elevated serum liver enzymes and elevated liver enzymes. Between July 24 and July 26, 2012 the owner applied melaleuca alternifolia oil to the dog. Several hours after the owner noticed those signs, she took the dog to the veterinarian, where the dog was given an enema and a flea product was applied to the dog. Between July 25 and July 27, 2012 the owner observed that the dog was paralyzed. Later during that same time range, the owner believed the dog was also exposed by an unknown route to the Vet Kem spray product. Several hours later, during that same time range, the owner observed that the dog was ataxic and was licking. Between July 26 and July 28, 2012, the owner noticed that the dog had fecal incontinence; later on, the owner also observed that the dog was no longer paralyzed or ataxic and had recovered from the fecal incontinence as well. On July 28, 2012 the owner observed that the dog's pre-existing liver enzyme elevations worsened. On August 1, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the risk with the melaleuca alernifolia oil was for ataxia, weakness, hypothermia, and even collapse and that very rarely liver enzyme elevations could be seen. The APSS veterinarian also stated that if the Vet Kem spray product had been ingested, nothing more than mild gastrointestinal (GI) upset would be expected and that if the dog was exposed dermally, dermal irritation could be seen. The APSS veterinarian said that nothing more than mild dermal irritation would be expected from an exposure to the flea product that the owner's regular veterinarian applied to the dog. The APSS veterinarian recommended that the owner take the dog to the veterinarian, have the veterinarian call for information, have the veterinarian perform a diagnostic evaluation, and call back with questions.

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To be determined by Registrant

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

Major

19. Provide supplemental information here

The APSS veterinarian stated that the melaleuca alternifolia oil was considered to have a medium likelihood of causing the clinical situation and that that the Vet Kem spray product and the flea product applied directly to the dog were considered to have a doubtful likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected.