Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3870

2. Registrant Information.

Registrant Reference Number: 2015TH282

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

Address: 2920 Matheson Blvd

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L9W 5R6

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

Domestic Animal

4. Date registrant was first informed of the incident.

05-AUG-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

04-OCT-13

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).

owner applied collar to adult female dog June 29 2013

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Rottweiler

4. Number of animals affected

5

5. Sex

Unknown

6. Age (provide a range if necessary )

0

7. Weight (provide a range if necessary )

Unknown

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

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

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Weight loss
  • Specify - underweight
  • Symptom - Loss of appetite

• General
  • Symptom - Abnormal behaviour

• Respiratory System
  • Symptom - Respiratory distress

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

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 29-Jun-2013, 6 year old, 90 pound, intact female, Rottweiler canine, in good condition, with no known concomitant medical conditions, had 1 Seresto Large Dog collar (Flumethrin-Imidacloprid) placed around the neck by the owner.On an unknown date in July the dog was bred, and became pregnant. The collar was worn continuously through the pregnancy which is an off label use of the product.On the evening if 04Oct2013 through 05Oct2013, the dog whelped a litter of 7 puppies,which were exposed to the treated bitch, all were under weight. All began to nurse immediately after birth. Within 6-8 hours of birth the pups were no longer nursing and were moving away from the bitch. The owner began syringe feeding by placing drops of milk in the mouth. Then pups were arching their backs and having respiratory distress within 12 hours. 5 pups died by 06 Oct 2013. The bitch and pups were not examined by a veterinarian. 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 Off-label use as collar was worn during pregnancy and lactation by bitch and newborn puppies had contact to treated bitch. Laboratory studies with either flumethrin or imidacloprid in rats and rabbits have not produced any effects on fertility or reproduction and showed no teratogenic, or foetotoxic effects. Thus, no side effects are expected with use on pregnant or lactating bitches,however the safety of the veterinary medicinal product has not been established in target animals during pregnancy and lactation. The collar was tolerated well by the bitch during pregnancy. Fatal outcome of puppies is neither expected nor in line with pharmaco-toxicological product profile and rather due to other causes. No necropsy of dead puppies performed, however numerous other causes have to be considered. In the end, a product relation is deemed to be not assessable.