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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7470

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0064982 (Report 451008)

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.

05-OCT-17

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

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. 11556-142

Product Name: K9 advantix II medium dog

  • 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.

1

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).

On an unspecified date in Jul 2017, a 16 year old, 15 pound, male, Bichon Frise canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Medium Dog (Imidacloprid-Permethrin-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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Bichon Frise

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

16

7. Weight (provide a range if necessary )

6.804

kg

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

  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Abnormal behaviour
    • 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?

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 Aug 2017, the dog was seen by the veterinarian and administered unspecified vaccinations. Approximately 8 hours post administration, the dog had a seizure. The dog was examined by the veterinarian; it was unspecified if any treatments were performed. Approximately 2 weeks post vaccination, in Sep 2017, the dog had another seizure and a behavior change. The caller contacted Bayer Animal Health to inquire about product use and not to report this event. On 2-Oct-2017 the dog died. It is unknown if a necropsy was performed. Follow up information received on 5th October 2017: Approximately 2 weeks post vaccination, in Sep 2017, the dog had another seizure and a behavior change. On 2-Oct-2017 the dog died. It is unknown if a necropsy was performed. No further information is expected; case is closed. The caller contacted Bayer Animal Health to inquire about product use and not to report this event.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely At recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dogs neither alone nor in combination. Only mild neurological signs, e.g. tremors or ataxia, may occur even after licking. Time to onset unknown, but seems long. Dog tolerated previous applications well, without neurological signs. Behavioural change is an unspecific sign and may have numerous other causes. Death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Other causes are more probable. Time to onset too long. No signs of allergy or anaphylactic reaction reported. The caller contacted Bayer Animal Health to inquire about product use and not to report this event. Considering overall aspects, a product relation is deemed to be unlikely.