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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-6518

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0050778

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.

08-AUG-17

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

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 pipette size unknown

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

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

Product Name: K9 Advantix Spot-on pipette size unknown

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %

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

Product Name: K9 Advantix II pipette size unknown

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .44 %

7. b) Type of formulation.

Other (specify)

Spot-on

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 unknown date in 2005, an approximately 2 year old, Newfoundland canine, of unknown weight, reproductive status, and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage (dog-unspecified) topically by the owner. On unknown date in approximately 2011, the canine was administered 1 tube of K9 Advantix (unspecified) and in approximately 2014, the canine was administered 1 tube of K9 Advantix II (unspecified) by the owner.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Newfoundland

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

2

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

>1 wk <=1 mo / > 1 sem < = 1 mois

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?

Unknown

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 unknown date in 2005, an approximately 2 year old, Newfoundland canine, of unknown weight, reproductive status, and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage (dog-unspecified) (Imidacloprid) topically by the owner. On unknown date in approximately 2011, the canine was administered 1 tube of K9 Advantix (unspecified) (Imidacloprid - Permethrin) topically by the owner. On an unknown date in approximately 2014, the canine was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On an unknown date in 2014, the canine died at the age of 11 years old. It is unknown if the canine was euthanized or if a necropsy was performed. No further information is expected. This case is closed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss a suspected flea efficacy issue with another Bayer product with current household dog and was 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

Advantage Spot-on pipette size unknown N - Unlikely Death is not expected as inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Moreover, in case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 9 years). Rather, the reason for the initial call was to discuss a suspected flea efficacy issue with another Bayer product with current household dog and was not to report the death of the patient. Animal died at an advanced age and thus alternative causes commonly seen in geriatric animals are more likely. Considering the known safety profile of the product, intent of the caller and long time to onset, even though some information is missing (e.g. necropsy results), a product relation is unlikely. Advantix Spot-on pipette size unknown N - Unlikely Death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Time for reporting is too long (3 days) as the intent of the phone call to Bayer was to discuss a suspected flea efficacy issue with another Bayer product with current household dog and was not to report the death of the patient. No signs of allergy/anaphylactic reaction reported. Other etiologies more probable in this geriatric dog. Finally, though very low level of information (age, medical history and time to onset unknown - necropsy not available), considering known product profile, a product connection is deemed to be unlikely. Advantix Plus Spot-on pipette size unknown N - Unlikely Death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Time for reporting is too long (3 days) as the intent of the phone call to Bayer was to discuss a suspected flea efficacy issue with another Bayer product with current household dog and was not to report the death of the patient. No signs of allergy/anaphylactic reaction reported. Other etiologies more probable in this geriatric dog. Finally, though very low level of information (age, medical history and time to onset unknown - necropsy not available), considering known product profile, a product connection is deemed to be unlikely.