Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-5597

2. Registrant Information.

Registrant Reference Number: 140096259

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-14

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

31-JUL-14

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. 2724-815

Product Name: Kirkland Signature Flea and Tick Control for Dogs 80 Lbs and Over

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 3.6 %
  • ETOFENPROX
    • Guarantee/concentration 30 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 5 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

9

Units: mL

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 July 31, 2014 the owner applied the product onto the dog for the first time as she noticed a tick.

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

Golden Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7.6

7. Weight (provide a range if necessary )

90.0

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

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

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Disorientation

• General
  • Symptom - Abnormal behaviour
  • Specify - Behavior Change

• Skin
  • Symptom - Dermatitis
  • Specify - Acute Moist Dermatitis

• Blood
  • Symptom - Anemia

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Other
  • Specify - Bloody Discharge

• Skin
  • Symptom - Blister

• Gastrointestinal System
  • Symptom - Retching

• General
  • Symptom - Vocalizing

• Nervous and Muscular Systems
  • Symptom - Abnormal posture
  • Specify - Abnormal Posture

• General
  • Symptom - Abnormal behaviour
  • Specify - Rolling

• Nervous and Muscular Systems
  • Symptom - Difficulty walking
  • Specify - Difficulty Walking
  • Symptom - Collapse

• Blood
  • Symptom - Thrombocytopenia
  • Symptom - Hypokalemia

• Liver
  • Symptom - Elevated liver enzymes

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Mental Dullness

• Liver
  • Symptom - Hepatomegaly

• General
  • Symptom - Abnormal behaviour
  • Specify - Circling

• Nervous and Muscular Systems
  • Symptom - Head tilt

• Eye
  • Symptom - Decreased vision
  • Specify - Impaired vision

• Ear
  • Symptom - Other
  • Specify - Otitis Externa

• Gastrointestinal System
  • Symptom - Rectal hemorrhage

• 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?

Unknown

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 July 31, 2014 the owner noticed the dog was lethargic, disoriented, had a behavior change (like he can't hear or see), was circling, had a head tilt, and had impaired vision. On August 1, 2014 the owner noticed acute moist dermatitis and the dog was anemic, so the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated sometimes can see a dermal hypersensitivity reaction with any spot on product and the concern is for something else causing the signs. The attending veterinarian also contacted the APSS on August 1, 2014 to discuss the case. The APSS assistant recommended taking the dog to the veterinarian, having the veterinarian call for information, and calling back with questions.

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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 not considered to be related to causing the clinical situation. A follow up was not performed, because additional information was not expected. On August 19, 2014 the owner called the APSS back to update the case. The owner stated she took the dog to the veterinary clinic on August 1, 2014 where they bathed the dog with liquid dish washing detergent (LDWD), performed a diagnostic evaluation, prescribed cephalexin, diphenhydramine, and prednisone which were started that day. On August 2, 2014 the owner took the dog back to the veterinary clinic as he was still having central nervous system (CNS) signs. On August 7, 2014 the lethargy, disorientation, and behavior changes ended. On August 13, 2014 the owner gave another dose of diphenhydramine and prednisone as the hot spot flared up again and the dog was diagnosed with otitis externa. On August 14, 2014 the owner put an elizabethan collar (e-collar) on the dog and gave another dose of diphenhydramine. On August 15, 2014 the owner noticed the dog had vomited and later that day they found bloody discharge on the floor, which appeared to come from the dog's rectum. The owner then took the e-collar off and took the dog back to the veterinarian. The veterinary clinic noticed blood coming from the penis and blistering in the rectal/anal area and rectal hemorrhage. The attending veterinarian performed a urinalysis, rectal examination, and sent the dog home on a different antibiotic and told the owner to apply a warm compress to the hot spot and anal areas, along with starting a bland diet. Later that night the dog had a behavior change, started retching, vomiting, and groaning. The dog had a hunched appearance, was rolling, and was having trouble walking, and eventually collapsed. The owner took the dog to the veterinary clinic again where they checked radiographs which showed hepatomegaly and blood work showed thrombocytopenia, hypokalemia, and elevated liver enzymes. The veterinary clinic placed an intravenous (IV) catheter and started the dog on fluids. On August 16, 2014 the owner spoke with the clinic who stated the dog showed mental dullness. Later that day, the owner went to the veterinary clinic where they discussed where the ticks were found, the dog was started on doxycycline and then transferred to another veterinary clinic. While in the car the dog moved around a bit and owner described the dog as laying belly up and weren't sure if he was breathing. When they arrived at the other veterinary clinic, cardiopulmonary resuscitation was performed, but the dog died. The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. The APSS veterinarian stated that lymphoma and hemangiosarcoma were considered to have an unknown likelihood of causing the clinical situation. A necropsy was not available.