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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5469

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0045256 (Report 511086)

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-18

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

07-MAY-18

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: K9advantixII 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 approximately 06-May-2018, a female dog of unknown signalment, in unknown condition, with the concomitant medical condition of congestive heart failure, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) via the topical route by the animal owner. On approximately 07-Jun-2018, the dog was administered an unspecified dose of doxycycline via the oral route by the animal owner. This was to be repeated daily with the last dose being on approximately 05-Jul-2018. The dog was also administered 1 tube of Advantage Multi for Dogs (10% imidacloprid + 2.5% moxidectin) Topical Solution (Imidacloprid and Moxidectin) Unknown via the topical route by the animal owner. On approximately 05-Jul-2018, the dog was administered 1 tube of Advantage Multi for Dogs (10% imidacloprid + 2.5% moxidectin) Topical Solution (Imidacloprid and Moxidectin) Unknown via the topical route by the animal 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

Unknown

4. Number of animals affected

1

5. Sex

Female

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?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
    • Symptom - Death
    • Symptom - Parasitism
    • Specify - Heartworm disease

12. How long did the symptoms last?

Persisted until death

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 approximately 07-May-2018, the dog developed lethargy, anorexia and decreased drinking. On approximately 08-May-2018, the dog presented to the veterinarian for an exam. A heartworm antigen test was performed, which was positive. The dog was administered an unspecified holistic heartworm treatment via the oral route by the animal owner. This was to be administered daily with the last dose being on 06-Jun-2018. On approximately 07-Jun-2018, the dog was administered an unspecified dose of doxycycline via the oral route by the animal owner. This was to be repeated daily with the last dose being on approximately 05-Jul-2018. On approximately 09-Jun-2018, the dogs decreased drinking worsened. On approximately 30-Jun-2018, the dogs lethargy improved slightly. On 08-Jul-2018, the dog passed away. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the phone call was to ask about a different pet, not to report the death in this event. 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

N - Unlikely Reported lethargy is an unspecific sign and may have numerous other causes. Anorexia and decreased drinking may be associated with reported lethargic status. Later reported death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Time to onset is over one day, therefore allergic/anaphylactic reaction can be ruled out. Moreover, the intent of the phone call to Bayer was to ask about a different pet, not to report the death in this event. Other causes are more probable, e.g. concomitant condition of congestive heart failure combined with heartworm infection. Advantix does not have efficacy against heartworm hence not product related. Though time to onset is consistent for initial signs, it is long (2 month) for death. Although no necropsy performed, sufficient information exist to ruled out a product relation.