Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0580

2. Registrant Information.

Registrant Reference Number: 2017KP083

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.

19-OCT-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 - Small 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 10Oct2016, a 12 year old, 9.5 pound, neutered, female,Chihuahua canine, in poor condition, with concomitant medical conditions of fleas, a skin disorder (NOS), who was on an unknown course of oclacitinib tablet, with wax and ulcerations in the right ear and prurlent discharge in the left ear, was bathed in an unspecified flea and tick shampoo,given an unknown dose of oral Nitenpyram, administered florfenicol/terbinafine/betamethasone acetate in her ears,then had 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar placed around her neck by the attending veterinarian.

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

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

9.5

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• General
  • Symptom - Death

• Skin
  • Symptom - Lesion

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 19Oct2016 the canine had betadine flush instilled in the ears and was started on gentamicin, mometasone and clomitrazole by the attending vet. On 21Oct2016, the canine had a reflush with the betadine solution and received an unknown dose of Deracoxib orally by the attending veterinarian. On 27Oct2016, the canine continued to have an ear infection. She was administered .43 ml of Cefovecin subcutaneously by the attending vet and was also administered 1 tube of Claro Otic Solution (Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate) instilled in the right ear by the attending vet. On 11Nov2016, the canine presented with abdominal lesions, application site lesions (Seresto Collar application site), and lesions along her back, so the Seresto collar was removed. She was started on an unknown dose of Baytril 22.7mg, was bathed in an idoine solution, followed by a cholorhexadine and topical solution. Follow-up received on 2016-12-28: On 20Nov2016, the canine 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

The reported application site disorders may occur in sensitive animals after product application. They are usually mild and transient. Signs consistent. Long time to onset. Unclear if correct fit of collar was checked periodically as recommended in the product information and thus development of signs not noticed. Skin disorders not expected on other than the application site is not typically seen with topical product administration. Time to onset long. Dog's medical history of skin disorders more likely cause the sign observed. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Time to onset long: death occurred several days after product has been withdrawn. Other products given concomitantly. Although no necropsy performed, product involvement is not likely, however due to limited information case is considered unassessable.