Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0557

2. Registrant Information.

Registrant Reference Number: 2017KP065

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.

27-JAN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

13-SEP-16

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 Dog

• 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 approximately 11-Sep-2016, an 8 year old, 32 pound,neutered, female, Spaniel (Cocker) canine, in good condition,with concomitant food allergies, had 1 Seresto Large Dog(Flumethrin-Imidacloprid) collar placed around the neck 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

Other

2. Type of animal affected

Dog / Chien

3. Breed

English Cocker Spaniel

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

32

lbs

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

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

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Stiffness
  • Symptom - Muscle weakness
  • Specify - Limb Weakness
  • Symptom - Shaking

• Gastrointestinal System
  • Symptom - Other
  • Specify - Distension of abdomen
  • Symptom - Diarrhea
  • Symptom - Weight loss

12. How long did the symptoms last?

Unknown / Inconnu

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 13-Sep-2016, the dog exhibited lethargy. On approximately 16-Sep-2016, the dog exhibited hind limb stiffness, hind limb weakness, generalized shaking, a distended abdomen, and diarrhea. On 19-Sep-2016, the dog was examined by a veterinarian. The dog was administered an unknown dose of cephalexin orally, an unknown dose of metronidazole orally, and an unknown dose of carprofen orally. On 20-Sep-2016, the collar was removed. On 21-Sep-2016, the lethargy was improved, however, all clinical signs continued. Follow up information received on 21st Oct 2016: On approximately 29-Sep-2016, the dog died; no necropsy was performed. It is unknown if the dog was re-examined by a veterinarian. No further information is expected. This case is closed. Follow up information received on 22st November 2016: On 23-Sep-2016, the dog was again examined by a veterinarian. A fecal exam and brief ultrasound were performed; the results are unknown. The dog was administered an unknown dose of furosemide via an unknown route, and unknown dose of desoxycorticosterone pivalatae via an unknown route and and unknown dose of sucralfate orally. On approximately 29-Sep-2016, the dog died; no necropsy was performed. It is unknown if the dog was re-examined by a veterinarian. No further information is expected. This case is closed.

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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

Reported lethargy is unspecific and may have numerous other causes. Musculoskeletal disorders are not expected after topical application of product, as these are inconsistent with pharmaco-toxicological product profile. Shaking is very unspecific and may be associated with musculoskeletal disorders. Digestive signs are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility) however mild gastrointestinal sign may occur shortly after product application. No oral product exposure reported. Time to onset is short for initial sign, but it is long for later reported signs. 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. Further, death occurred 9 days after collar removal. Several concomitant drugs administered in-between that may have contribute to the fatal outcome. Considering the known product profile, even though no necropsy was done, sufficient information exists to conclude that the product did not cause the event and product involvement was ruled out. Thus case considered to be unlikely.