Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-8027

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0075370 (Report 461294)

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

27-NOV-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

10-NOV-17

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 Small

• 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).

On 25-Oct-2017, a 14 year old, 5.4 pound, neutered, female, Domestic Longhair feline, in unknown condition, with concomitant medical conditions of fleas, inappetence, lethargy and anemia diagnosed by a veterinarian on 18Oct2017, had one Seresto Cat (Flumethrin-Imidacloprid) collar placed around by the owner. The feline had an unspecified topical flea medication applied by the owner on 16Oct2017.

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

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

Female

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

2.449

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Weight loss

• General
  • Symptom - Abnormal behaviour
  • Specify - Behavioural disorder NOS

• Renal System
  • Symptom - Other
  • Specify - Renal insufficiency

• 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?

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

Post collar application, the concomitant inappetance and lethargy resolved. On 10-Nov-2017, the inappetence recurred and the feline she developed a behavioral change, stopped grooming and weight loss.. On 20-Nov-2017, the cat was re-evaluated by the veterinarian and a chemistry profile performed revealed mild renal insufficiency. On 27-Nov-2017, the cat died. 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

N - Unlikely Reported behavioural signs and inappetance are unspecific and may have numerous other causes. Signs were present prior to collar application and thus considered not product related. Same applies for anemia. Weight loss and behavioural signs starting weeks after product application are not expected after topical product application however in this case may be a consequence of later reported renal insufficiency. Renal insufficiency and death are 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. Product has a wide safety margin. Involved animal was geriatric and may have died due to the renal insufficiency. Time to onset is long. Signs were unlikely product related as partly present prior to product use and most likely related to diagnosed renal insufficiency. Finally, a product involvement is unlikely.