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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-6634

2. Registrant Information.

Registrant Reference Number: 2016KP180

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.

18-OCT-16

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. 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 an unspecified date in 2015, a 8 year old, male, Unknown Breed feline, of unknown weight and condition, no concomitant medical conditions, was administered unknown dose of (s)-methoprene topically by the owner. Also on unspecified dates in 2015 the cat was administered 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

Unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

Unknown

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Respiratory System
    • Symptom - Dyspnea
  • Skin
    • Symptom - Pruritus

12. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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 2016, the cat developed pruritus and fleas. On 09-Sep-2016, the cat was administered an unknown dose of a cortisone injection by the attending Veterinarian. The cat also had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner. Approximately 8 hours post application the cat seemed to have difficulty breathing, the cat was not examined by a veterinarian. On 10Sep2016, the cat died. It is unknown if a necropsy was performed. No more 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

Pruritus is not expected with appropriate topical product use. If any, skin reactions would be located at the application site. Time to onset is unknown. Reported breathing difficulty and subsequent death are not expected after topical application of product, moreover these sign occurred in close proximity of another product application. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold over dosage tolerated by cats without showing any side effect. Time to onset exceptionally long. However, presence of fleas is not a sign of inefficacy. Regular treatments for at least a 6-week period are necessary in order to break the flea development circle. Otherwise preexisting pupae may still emerge from the environment and re-infest the pet. Efficacy against fleas can be expected only after this period. In the end SLEE not evident. Moreover, serious sign occurred long time after treatment and in close proximity to another product application. Overall, a product involvement is considered unlikely.