Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4024

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0022976

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.

Human

Domestic Animal

4. Date registrant was first informed of the incident.

30-JUN-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Collar Large

• Active Ingredient(s)
  • FLUMETHRIN
  • Imidacloprid
    • Guarantee/concentration 10 %

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7. b) Type of formulation.

Other (specify)

collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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 Seresto Large Dog (Flumethrin-Imidacloprid) collar when he mouthed his dog that had the collar applied on the same day. No known direct exposure with the collar occurred and it was unknown if the collar was applied correctly to the dog.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Numbness
  • Specify - numbing sensation on the tongue

4. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

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

No

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Unknown

8. How did exposure occur? (Select all that apply)

Contact with treated area

Amount of time between application and contact .033

Hour(s) / Heure(s)

What was the activity? mouthed his dog that had the collar applied

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Oral

11. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

On an unspecified date in approximately Oct 2016, a (age) year old, man, in unknown condition, with a concomitant medical condition of allergies, was exposed to an unknown amount of 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar when he mouthed his dog that had the collar applied on the same day. No known direct exposure with the collar occurred and it was unknown if the collar was applied correctly to the dog. Immediately post exposure, the individual experienced an intermittent numbing sensation on the tongue. The man continued to mouth his dog and the sign continued intermittently. On an unknown date in Apr 2017, the man removed the collar from the dog and recovered without medical intervention. Follow up information received on 6th Jun 2017: No more information is expected; this case is closed.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

B - Possible No known direct contact reported but indirect contact can be assumed as individual mouthed the dog. Reported sign may occur after oral exposure. Though, individual has concomitant condition of allergies, considering short time to onset, a product relation is possible.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Australian Shepherd Dog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

20.412

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Loss of appetite
  • Specify - Decreased appetite

• General
  • Symptom - Death

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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 05-May-2017, a 9 year old, 45 pound, neutered, male, Shepherd - Australian dog, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog Collar (Flumethrin-Imidacloprid) placed around the neck by the animal owner. On approximately 06-May-2017, the dog developed a decreased appetite. On 08-May-2017, the dog died and no necropsy was performed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

O - Unclassifiable/unassessable Reported anorexia is unspecific and may have numerous other causes. Time to onset is short. Further death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Considering the product profile, product involvement is deemed unlikely, however due to missing information (no necropsy report), case is considered unassessable.