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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4007

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0018583

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.

30-JUN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

26-APR-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)

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

Product Name: Seresto Collar Small Dog

  • Active Ingredient(s)
    • FLUMETHRIN
      • Guarantee/concentration 4.5 %
    • IMIDACLOPRID
      • Guarantee/concentration 10 %

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).

A Dachssund canine, owas exposed to an unknown amount of 1 Seresto Small Dog collar as it was born to a 5 year old, 10 pound, female, lactating, Dachshund canine who was wearing the Seresto Small Dog (Flumethrin-Imidacloprid) collar that was placed around the neck by the owner. This is extra-label use of the product as the product has not been studied in pregnant or lactating animals.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Dachshund (Standard)-Kurzhaar

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • General
    • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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?

Other / Autre

specify Secondary Exposure

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 26-Apr-2017, a Dachssund canine, of unknown signalment, in unknown condition, with no known concomitant medical conditions was exposed to an unknown amount of 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar as it was born to a 5 year old, 10 pound, female, lactating, Dachshund canine who was wearing the Seresto Small Dog (Flumethrin-Imidacloprid) collar that was placed around the neck by the owner on 01Apr2017. This is extra-label use of the product as the product has not been studied in pregnant or lactating animals. Approximately 1 hour post birth, the puppy died. The puppy was not examined by a veterinarian and no treatments were performed. No necropsy was performed. No more information is expected. This case is closed.


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 This was off label use as the safety of the veterinary medicinal product has not been established in target animal during pregnancy and lactation however laboratory studies with either flumethrin or imidacloprid in rats and rabbits have not produced any effects on fertility or reproduction and showed no teratogen or foetotoxic effects. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. 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. The collar was worn by the mother for only 26 days, and it is highly unlikely that it could have caused the serious outcome of the puppy. Moreover, route of exposure to the product and reason for death is unspecified in this case. Time to onset is not consistent. Overall considering the limited amount of information, no veterinary examination or necropsy performed, product relation is unassessable.