Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-4348

2. Registrant Information.

Registrant Reference Number: 150052418

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.

23-APR-15

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW JERSEY

6. Date incident was first observed.

08-APR-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. 2724-829-89459

Product Name: Adams Pentagon Flea And Tick Spot On For Extra Large Dogs 61-150 Lbs

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .23 %
  • ETOFENPROX
    • Guarantee/concentration 50 %
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration .91 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .45 %

---

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.247

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 April 6, 2015 the owner applied the product to the dog for the first time as prevention.

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

Old English Sheepdog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

95.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Hyperthermia

• Nervous and Muscular Systems
  • Symptom - Lameness

• Gastrointestinal System
  • Symptom - Retching
  • Symptom - Diarrhea
  • Symptom - Anorexia

• General
  • Symptom - Adipsia
  • Symptom - Lethargy

• Blood
  • Symptom - Leukopenia
  • Specify - Neutropenia
  • Symptom - Other
  • Specify - Dohle Bodies

• Cardiovascular System
  • Symptom - Tachycardia

• Nervous and Muscular Systems
  • Symptom - Depression
  • Symptom - Abnormal gait
  • Specify - Stiff Gait

• General
  • Symptom - Hesitancy to move
  • Symptom - Other
  • Specify - Lymphadenopathy
  • 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?

1

Day(s) / Jour(s)

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 April 8, 2015 the dog developed lameness and hyperthermia with a temperature of 103.5 degrees Fahrenheit (deg F), so the owner took the dog to the veterinarian where a carprofen injection was given and prescribed and laser therapy was performed. On April 13, 2015 the dog started retching, having diarrhea, developed anorexia, and adipsia, and lethargy. On April 16, 2015 the owner took the dog to the veterinarian where the lameness had ended, the carprofen was discontinued, the dog's hyperthermia continued with a temperature of 103.6 deg F. The dog was given maropitant and fluid therapy (subcutaneous (SQ)). On April 17, 2015 the dog went back to the veterinarian where a urinalysis was performed (owner let the attending veterinarian know that the dog had been incontinent for a month), the dog was diagnosed with neutropenia and dohle bodies, and cephalexin (1000 milligrams every 12 hours (mg q 12) was prescribed. On April 21, 2015 the dog returned to the veterinarian where the lethargy worsened and the hyperthermia had become severe; with the dog's temperature at 107.2 deg F and the dog developed tachycardia with a heart rate of 150 beats per minute (bpm). The dog was also depressed, had a stiff gait, and was hesitant to move. The dog was hospitalized for supportive care, given an antibiotic, a tick profile performed (negative 4 DX and Tick PCR), and referred to a specialist. On April 22, 2015 the veterinary specialist performed bone marrow aspiration (most consistent with "toxic" changes, dysplasia shown), radiographs (thoracic and adominal), a joint tap, and an ultrasound. The dog was prescribed doxycycline (200 mg q 12) and metoclopramide (10 mg q 12) and the dog was discharged from the specialist's hospital with lymphadenopathy (left popliteal lymph node (LN) is enlarged) and the neutropenia becoming severe. On April 23, 2014 the dog's hyperthermia ended and the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated dermal hypersensitivity and paresthesia may be seen. The APSS assistant recommended the owner have the attending veterinarian call for information. On April 24, 2015 the attending veterinarian called the APSS to discuss the case. The attending veterinarian stated that the diagnosis was still open and the APSS veterinarian stated that these signs are not expected from the spot on, that chemotherapy medications and topical creams should be considered. The attending veterinarian stated that she had already asked the owner about medications, creams, etc.

---

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 April 29, 2015 an APSS technician called the owner to follow-up on the case. On May 2, 2015 the owner called the APSS and stated the dog had died on April 28, 2015, no necropsy had been done as the dog had been cremated. The owner stated that there had been no final diagnosis; it was still an unknown toxic insult to the dog's bone marrow.