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Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2010-1535

2. Registrant Information.

Registrant Reference Number: 090140623

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.

20-DEC-09

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

20-DEC-09

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. 2724-491-270

Product Name: Adams Plus Breakaway Flea and Tick Collar for Cats and Kittens

Active Ingredient(s)
- (S)-METHOPRENE
  - Guarantee/concentration 2.1 %
- PROPOXUR
  - Guarantee/concentration 10 %

7. b) Type of formulation.

Other (specify)

Collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

Other Units: collar

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 December 19, 2009 the owner put a collar onto both of her cats to treat for fleas.

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

Cat / Chat

3. Breed

Domestic Mediumhair

4. Number of animals affected

5. Sex

Male

6. Age (provide a range if necessary )

7. Weight (provide a range if necessary )

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

Renal System
- Symptom - Urinary incontinence

Skin
- Symptom - Pale mucous membrane colour

Respiratory System
- Symptom - Shortness of breath
- Specify - Shallow Breathing

Eye
- Symptom - Pupil dilation

General
- Symptom - Vocalizing

Nervous and Muscular Systems
- Symptom - Seizure

Cardiovascular System
- Symptom - Cardiac arrest

Respiratory System
- Symptom - Difficulty Breathing
- Specify - Abnormal Breathing
- Symptom - Apnea

General
- Symptom - Death

Liver
- Symptom - Other
- Specify - necrosis

Blood
- Symptom - Hypoxemia

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?

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 December 20, 2009 the APSS veterinarian stated dermal irritation or a contact hypersensitivity may occur as with any topical exposure; and if the collar was licked, hypersalivation and gastrointestinal upset may occur. She also stated that propoxur is a carbamate which can cause muscarinic SLUDDE (salivation, lacrimation, urination, defecation, dyspnea, and emesis) signs, as well as nicotinic signs. She stated that systemic signs are not likely following exposure to the propoxur in the collar. The APSS veterinarian recommended taking the cat to the veterinarian for a diagnostic evaluation, that the attending veterinarian provide supportive and symptomatic care, and that he/she call for information. The owner declined these recommendations as she wouldn't be able to take the cat to the veterinarian until the following morning (December 21, 2009).

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 December 22, 2009 the owner called the APSS to update the case. She reported on December 21, 2009 the cat had mydriasis, and when the she bathed him and she noticed a lot of blood in the bath. She then stopped bathing and wrapped him in a towel. The cat then began to vocalize, and the owner called her veterinarian. The owner took the cat to the veterinarian on December 22, 2009 where thermoregulation ,a feline leukemia test, a feline immunodeficiency virus test, and a heartworm test were done. On December 23, 2009 the owner called the APSS to update the case. She stated that on December 23, 2009 the cat's serum potassium and red blood cell count were tested. Later that morning the cat had a seizure, went into cardiac arrest, had abnormal breathing and apnea; so the clinic performed cardiopulmonary resuscitation. The cat died shortly after. The veterinarian recommended a necropsy, but the owner declined.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

5. Sex

Female

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

General
- Symptom - Lethargy

Blood
- Symptom - Hypokalemia
- Symptom - Anemia

General
- Symptom - Other
- Specify - Moribund

Nervous and Muscular Systems
- Symptom - Seizure

General
- Symptom - Death

Blood
- Symptom - Hypoxemia

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?

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 December 24, 2009 the owner removed the collar from the cat. On January 2, 2010 the owner took the cat to the veterinarian where symptomatic care was provided by giving potassium gluconate and dexamethasone. The cat's serum potassium, hematocrit, and reticulocytes were all tested; and it was determined by the veterinarian the cat had decreased blood potassium, anemia, and was moribund. On January 3, 2009 the APSS veterinarian recommended a blood transfusion, which the owner declined due to finances. The APSS veterinarian also recommended a necropsy if the cat died.

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. After the APSS consultation on January 3, 2010, the cat had a seizure and died. Necropsy results are pending.