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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-3260

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2015-US0056277

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: UNKNOWN

6. Date incident was first observed.

Unknown

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. 11556-151

Product Name: Advantage II Small Cat

  • Active Ingredient(s)
    • Imidacloprid
      • Guarantee/concentration 9.1 %
    • Pyriproxifen
      • Guarantee/concentration .46 %

7. b) Type of formulation.

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).

1 Tube/Pipette 1 Days 1 Dose

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 Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8.5

7. Weight (provide a range if necessary )

3.402

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Death

12. How long did the symptoms last?

>6 mos / > 6 mois

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

Yes

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 an unspecified date in approximately 2011, a 8.5 year old, 7.5 pound, neutered, male, Domestic Shorthair feline, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. Approximately 10 minutes post application the cat fell over and was ataxic. The owner immediately bathed the cat with dish soap and the cat recovered within approximately 1 hour. The cat was not treated further with the product and died on an unspecified date in approximately 2013. No necropsy was performed. No further information is expected. This case is closed. The reason for the initial call was to discuss the use of our product on another animal, and not to report the death of the patient.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely Falling and ataxia are typically observed with appropriate topical product administration. Product was used before without causing signs, an appropriate dosage was applied and no oral product exposure reported. Hence, other causes have to be considered. The reason for the initial call was to discuss the use of our product on another animal, and not to report the death of the patient. Nevertheless death is inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Moreover, cat did not receive the product for two years prior to the death. Even though time to onset for initial signs is short it is exceptionally long for serious outcome. Finally, considering chronology of the signs and known product profile, a product relation is considered to be unlikely.