Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-2150

2. Registrant Information.

Registrant Reference Number: 2017KP096

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.

19-APR-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

17-DEC-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)

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: advantage II unknown

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

---

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 16-Dec-2016, an 18 year old, 9 pound, neutered, female,Siamese crossbred feline, in unknown condition, with no known concomitant medical conditions, was administered 1tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner.

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

Other

2. Type of animal affected

Cat / Chat

3. Breed

Siamese Crossbreed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

18

7. Weight (provide a range if necessary )

9

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

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia
  • Symptom - Bad breath

• Cardiovascular System
  • Symptom - Other
  • Specify - Cardiac Enlargement

• General
  • Symptom - Abnormal behaviour

• Renal System
  • Symptom - Renal failure
  • Specify - Renal Insufficiency - Elevated creatinine; elevated BUN

• Nervous and Muscular Systems
  • Symptom - Convulsions
  • Symptom - Seizure

12. How long did the symptoms last?

Unknown / Inconnu

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?

Unknown

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 17-Dec-2016, the cat exhibited lethargy, anorexia, and halitosis. On 18-Dec-2016, the cat exhibited adipsia. The anorexia and lethargy continued, and the halitosis worsened. The owner bathed the cat in an unspecified olive oil based pet soap. The cat was not seen by a veterinarian and the clinical signs continued. Follow up received on 23th Dec, 2016: On 17-Dec-2016, the cat exhibited lethargy, a behavioral change, anorexia, and halitosis. On 18-Dec-2016, the cat exhibited adipsia. The anorexia and lethargy continued, and the halitosis worsened. The owner bathed the cat in an unspecified olive oil based pet soap and washed the neck area in dish soap 3 times. On 19-Dec-2016, the cat was examined by a veterinarian, unspecified tests were performed that revealed increased kidney function and an enlarged heart. On 23-Dec-2016, the halitosis resolved but the additional clinical signs continued. Follow up received on 6th Feb, 2017: On 19-Dec-2016, the cat was examined by a veterinarian and blood work was performed that indicated an increased value for BUN of 105 mg/dl and an increased value for Creatinine of 9.5 mg/dl. The cat was also diagnosed with an enlarged heart. On 23-Dec-2016, the halitosis resolved but the additional clinical signs continued. On unknown date in approximately Jan 2017, the feline was evaluated again by a veterinarian. The feline was administered and unknown amount of subcutaneous fluids, and this continued at home twice daily. It is unknown if any other therapies were performed. On unknown date in Jan-2017 the feline had one seizure that resolved within approximately 5 minutes, was examined by a veterinarian, was hospitalized, and placed on intravenous fluids at an unknown rate. On unknown date in Jan-2017, the feline died. No necropsy was performed. No further information is expected. This case is closed.

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

The product is not expected to cause halitosis in the treated cat. As oral ingestion of product was not reported, other causes (e.g. diet, tartar) have to be considered in this case. Apart from that, the smell of any agent is subjective to the individual concerned. The earlier reported systemic and behavioral signs are associated with halitosis. Worsening and continuation of signs is not expected either. Subsequently diagnosed enlarged heart, elevated BUN and elevated creatinine are not anticipated with topical use of Advantage as not consistent with its pharmaco-toxicological product profile. The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Death is also not expected following appropriate topical product application as inconsistent with product¿¿¿¿¿¿s pharmacological profile. The cause of death was renal disorders and cardiac enlargement. Moreover, animal involved in this case was geriatric. Time to onset is short for earlier reported signs while long for later reported renal disorders, seizures and death. Overall, even though no necropsy was performed considering known safety profile of the product and the serious outcome of death product relation is deemed to be unlikely.