Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-3253

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2015-US0051948

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.

01-JUN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: SOUTH CAROLINA

6. Date incident was first observed.

01-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. 11556-151

Product Name: advantage II small cat

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

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7. b) Type of formulation.

Other (specify)

Spot-on soloution

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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).

One tube of Advantage II Small Cat 0.4 ml (Imidacloprid-Pyriproxyfen) applied topically by the owner. Weight and age of animal unknown

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

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

Limited information was provided by the reporting party in the initial phone call communication; attempts to obtain relevant details have been unsuccessful to date. On 29Sep2015, a male, feline, of an unknown age and with an unknown weight, in fair condition, with fleas, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On 01Oct2015, the cat was at a veterinary clinic and received unspecified anesthesia for a routine castration. He also had an unspecified application of spinetoram topically. Approximately 12 hours post surgery and the application of spinetoram the cat passed away. It is unknown if a necropsy was performed. No further information expected. Case 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 Death not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral LD50 in rat is 642 mg/kg BW and a 24-fold overdosage is tolerated by cats without showing any side effect. Time to onset a bit long. No signs of allergic/anaphylactic reaction reported. Rather, other causes reported in this case such as surgery for castration and other concomitant medications administered in closer proximity to the sign were more likely responsible for death. Considering all aspects, although it is unknown if necropsy was performed and animal particulars were not available, product relation was deemed unlikely.