Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-7161

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0067285 (Report 609834)

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.

11-NOV-19

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

23-OCT-19

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 Small Dog

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

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Advantage II pipette size unknown

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Advantix Plus Spot-on pipette size unknown

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .44 %

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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 7-Aug-2019, a Dachshund puppy, of unknown signalment and condition, with no known concomitant medical conditions, was secondarily exposed to an unknown amount of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) applied topically to the dog while the puppy was in utero. On 21-Aug-2019, was secondarily exposed to an unknown amount of 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar when it was placed around the neck of the dog while the puppy was in utero. On 28Aug2019 the puppy was secondarily exposed to an unknown amount of Advantage II (unspecified) (Imidacloprid-Pyriproxyfen) when it was applied topically to the dog while the puppy was in utero.

To be determined by Registrant

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

Unknown

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

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

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?

Treatment / Traitement

17. Provide any additional details about the incident

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

On 23-Oct-2019, the puppy was whelped and died. No necropsy was performed. 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

Seresto Collar Small (1.25 g Imi / 0.56 g Flum) N - Unlikely The puppy was secondarily exposed to collar when it was placed around the neck of a dog while the puppy was in the uterus. The safety of the veterinary medicinal product has not been established in target animals during pregnancy and lactation however laboratory studies with either flumethrin or imidacloprid in rats and rabbits have not showed any teratogenic or foetotoxic effects. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin when wearing the collar. Thus, death of offspring is not expected following appropriate topical product application to the parent as inconsistent with pharmaco-toxicological product profile. Also no abnormalities reported during the foetal development. Further, no signs of anaphylaxis reported post whelping as well. Other unrelated causes are more probable. Finally, a product relation is considered unlikely. Advantage Plus Spot-on pipette size unknown N - Unlikely The puppy was secondarily exposed to the product when it was applied topically to a dog while the puppy was in uterus. Although studies in pregnant and lactating together with their offspring are limited, evidence so far suggests that no adverse effects are to be expected in these animals. Thus, death of offspring is not expected following appropriate topical product application to the parent as inconsistent with pharmaco-toxicological product profile. Also no abnormalities reported during the foetal development. Further, no signs of anaphylaxis reported post whelping as well. Other unrelated causes are more probable. Finally, a product relation is considered unlikely. Advantix Plus Spot-on pipette size unknown N - Unlikely The puppy was secondarily exposed to the product when it was applied topically to a dog while the puppy was in uterus. Reported sign is not expected after product application. In clinical studies with 1 to 3 times the recommended dosage at different stages of pregnancy and lactation, no negative effects were observed in the bitches nor the offspring. Further, dermal absorption of the product is minimal. Other causes are likely, e.g. intra-uterine infection. Time to onset is not consistent. Considering all aspects, a product connection is deemed unlikely.