Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0697

2. Registrant Information.

Registrant Reference Number: 2015KP332

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

Address: 2920 matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

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

Domestic Animal

4. Date registrant was first informed of the incident.

15-JAN-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

25-OCT-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-120

Product Name: advantage 55

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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 24-Oct-2015, an 8 year old, 15 pound, neutered, male,Domestic Shorthair feline, in good condition, with no knownconcomitant medical conditions, was administered a partialtube of Advantage 55 Dog (Imidacloprid) topically by the owner. This is off label use as it was used on the incorrect species.

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 Shorthair

4. Number of animals affected

1

5. Sex

Male

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

15

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

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

11. List all symptoms

System

• General
  • Symptom - Lethargy
  • Symptom - Death

• Cardiovascular System
  • Symptom - Cardiac arrest

• Respiratory System
  • Symptom - Other
  • Specify - Hydrothorax
  • Symptom - Respiratory congestion

• Renal System
  • Symptom - Other
  • Specify - Nephritis
  • Symptom - Other
  • Specify - Nephropathy

• Blood
  • Symptom - Thrombocytopenia

• General
  • Symptom - Hiding
  • Symptom - Vocalizing

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Salivating excessively

• Renal System
  • Symptom - Urinary incontinence

• Cardiovascular System
  • Symptom - Other
  • Specify - Ventricular septal defect

12. How long did the symptoms last?

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

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 approximately 25-Oct-2015, the cat had hiding behavior, decreased vocalization, anorexia, lethargy and urinary tenesmus. On 28-Oct-2015, the cat had vocalization and was found by the owner deceased with evidence of hypersalivation. On 30-Oct-2015, a necropsy was performed. Gross diagnostic report indicated severe left ventricular and septal concentric hypertrophy and left atrial dilation; hydrothorax and pulmonary congestion; and chronic neprhitis unilateral (right) and acute cortical necrosis (left). Left-sided congestive heart failure and cardiac arrest due to primary hypertrophic cardiomyopathy were interpreted as the cause of death. The acute unilateral cortical necrosis of the left kidney was attributed to a vascular event (thromboembolism). No more information is expected. This 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

Offlabel use of the product occurred as dog product was used on cat. Reported signs hiding, decreased vocalization, anorexia, lethargy are unspecific and may be associated with urinary tenesmus. Moreover, urinary tenesmus is not expected after product application as sign is not in line with products pharmaco-toxicological profile. Time to onset is short though. Reported vocalization and hypersalivation are also unspecific and may have various other causes. Death not expected after product application, as inconsistent with pharmaco-toxicological product profile. As per necropsy results, animal was died due to cardiac arrest, thus death is not product related. Clinical conditions observed during necropsy are not in expected after product application as signs are not line with products pharmaco-toxicological profile. Product was used before without any side effects. No signs of allergic/anaphylactic reaction reported and time to onset is long for death. Considering all aspects, sufficient information exists to ruled out product relation completely. Overall, a product relation considered as unlikely.