Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-5171

2. Registrant Information.

Registrant Reference Number: 160087245

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.

16-JUN-16

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

10-JUN-16

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. 89459-4

Product Name: Adams for Cats Flea and Tick Spot On for 5 Lbs and Over

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 4.05 %
  • ETOFENPROX
    • Guarantee/concentration 45 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.58

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 June 6, 2016 the owner applied the product onto 2 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 Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

7.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Weight loss
  • Symptom - Anorexia

• General
  • Symptom - Adipsia
  • Symptom - Lethargy

• Respiratory System
  • Symptom - Tachypnea

• Nervous and Muscular Systems
  • Symptom - Seizure

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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 June 10, 2016 the cat developed weight loss, anorexia, adipsia, and lethargy. On June 13, 2016 the cat developed tachypnea, seizure, and died shortly after. On June 16, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated etofenprox is a non-ester pyrethroid and the mechanism of action (MOA) is similar to pyrethroids. A necropsy was not available.

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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.

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

1

5. Sex

Female

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

9.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Hiding
  • Symptom - Lethargy

• Respiratory System
  • Symptom - Dyspnea

• Skin
  • Symptom - Pale mucous membrane colour

• Gastrointestinal System
  • Symptom - Anorexia

• Blood
  • Symptom - Hypoxemia

• Respiratory System
  • Symptom - Other
  • Specify - pulmonary thrombus

• Liver
  • Symptom - Other
  • Specify - hepatocellular necrosis

• Cardiovascular System
  • Symptom - Other
  • Specify - rare focal arteriosclerosis

• Respiratory System
  • Symptom - Other
  • Specify - mild mutlifocal bronchiolar smooth muscle hyperplasia

12. How long did the symptoms last?

Persisted until death

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 June 13, 2016 the cat started hiding, became lethargic, and developed anorexia. On June 16, 2016 the owner noticed the cat had developed dyspnea, the owner then bathed the cat (Dawn; tons of fleas), and shortly after the cat developed white mucous membranes. A short time later, the owner noted the cat died in his arms. The owner then contacted the Animal Product Safety Service. The APSS veterinarian stated etofenprox is a non-ester pyrethroid and the mechanism of action (MOA) is similar to pyrethroids. The APSS veterinarian recommended a necropsy and provided information (how to store body and have veterinarian call us in the morning).

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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

On June 17, 2016 the veterinary staff called the APSS to inquire why they were involved or why the owner cannot submit the body himself. On June 19 and 20, 2016 the APSS technician attempted to contact the veterinary clinic to discuss the necropsy submission. On June 20, 2016 the veterinary staff returned the APSS technician's call and stated the body was in the freezer, the forms had been faxed to the clinic, she had already spoken with someone at the University of Illinois (U of I), and the package pickup was scheduled for that day or the next. On June 22 and 23, 2016 the APSS staff discussed private cremation with the owner, which the owner declined due to cost. On June 30, 2016 the veterinary staff contacted the APSS as they had received the necropsy results and were wondering how to proceed as they did not want to be involved since the patient was never seen at the facility. The APSS assistant stated that no APSS veterinarians were available to transfer so the clinic requested a call back the following day. On July 1, 2016 the APSS technician called the veterinary staff and provided the fax number so that the results could be faxed over. On July 7, 2016 the APSS received the final necropsy results. The necropsy revealed a pulmonary arterial thromboembolism and a mild multifocal bronchiolar smooth muscle hyperplasia, the heart a rare focal arteriosclerosis, the liver diffuse, severe, centrilobular to massive hepatocellular degeneration. The necropsy also stated the extent of autolysis is remarkable and may be obscuring clinically significant lesions. The necropsy further stated hepatocellular degeneration is suggestive of hypoxemia or toxicity. On July 7, 2016 the APSS veterinarian called the owner to discuss the necropsy results. The APSS veterinarian stated the most significant findings were a pulmonary thrombus and hepatocelluar necrosis with no definitive causes for these findings. The APSS veterinarian finally stated hypoxia from the flea anemia may have contributed to the hepatic damage, although this could not be confirmed due to autolysis.