Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3982

2. Registrant Information.

Registrant Reference Number: 2015TH247

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 Matheson Blvd

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L9W 5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

05-AUG-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

15-APR-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. 11556-155

Product Name: Seresto Collar - small dog

• Active Ingredient(s)
  • Flumethrin
  • IMIDACLOPRID
    • Guarantee/concentration 10 %

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7. b) Type of formulation.

Other (specify)

Collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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).

1 collar applied April 1 2013 by owner. Cat owner used small dog collar instead of cat.

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

Other

2. Type of animal affected

Cat / Chat

3. Breed

domestic long hair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

15.75

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

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

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Diarrhea
  • Symptom - Salivating excessively

• General
  • Symptom - Other
  • Specify - pancreatitis (pancreatic acinar atrophy)
  • Symptom - Lethargy

• Eye
  • Symptom - Pupil dilation

• Cardiovascular System
  • Symptom - Tachycardia
  • Symptom - Other
  • Specify - pericardial hemorrhage
  • Symptom - Shock

• Nervous and Muscular Systems
  • Symptom - Disorientation

• Respiratory System
  • Symptom - Pulmonary edema

• Liver
  • Symptom - Other
  • Specify - fatty liver
  • Symptom - Elevated liver enzymes
  • Symptom - Hyperbilirubinemia

• Blood
  • Symptom - Other
  • Specify - decreased sodium potassium ratio
  • Symptom - Leukocytosis
  • Symptom - Other
  • Specify - low MCHC
  • Symptom - Leukopenia
  • Specify - neutropenia
  • Symptom - Leukopenia
  • Specify - lymphopenia
  • Symptom - Other
  • Specify - low total t4
  • Symptom - Other
  • Specify - elevated lipase
  • Symptom - Other
  • Specify - elevated rbc/hct

• Renal System
  • Symptom - Creatinine increased

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 approximately 01Apr2013, a 3 year old, 15.75 pound, spayed, female, Domestic Longhair feline, in good condition, with a history of morbid obesity, had 1 Seresto Small Dog Collar (Flumethrin-Imidacloprid) placed around the neck by the owner. This is an off label use of the product as it is not labeled for use on cats. On 15Apr2013, the cat presented to the veterinary clinic with hypersalivation, vomiting, diarrhea, dilated pupils, lethargy, tachycardia, and acting "spacy" (disorientation). The cat received intravenous fluids and maropitant citrate as treatment. During the night of 16Apr2013, the cat's health continued to deteriorate. The cat when into shock and passed away at that time. Postmortem bloodwork revealed the following low values: Na/K Ratio, WBC, MCHC, Neutrophils, Lymphocytes, and Total T4. Postmortem bloodwork revealed the following high values: Albumin, AST (SGOT), ALT (SGPT), Total bilirubin, BUN, Creatinine, Triglycerides, Lipase CPK, RBC, and HCT. A necropsy showed the cause of death to be shock, although the underlying cause of the shock was not apparent in the gross necropsy. Microscopic findings were as follows: pulmonary edema, hepatic lipidosis, pancreatic acinar atrophy, and subendocardial hemorrhage. After the necropsy was completed, the cat was communally cremated. No more information is expected. Case is closed

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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

N- Unlikely. Time to onset not compatible with product use. No signs were seen for 2 weeks of wearing the collar. Reported symptoms, abnormal blood results and subsequent fatal outcome neither expected nor in line with pharmacotoxicologicalproduct profile. Reaction probably due to some unknown underlying disease. Based on the postmortem findings, the cause of death was not clearly defined, but probably associated with the cat's underlying condition of morbid obesity of animal. A product relation was considered unlikely.