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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-2205

2. Registrant Information.

Registrant Reference Number: 2017KP149

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.

19-APR-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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
    • 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).

On an unspecified date in approximately 2014, a 14 year old, 9 pound, neutered, female, Shih Tzu/Maltese crossbred canine, in fair condition, with concomitant alopecia, pruritus,atopy, a fungal skin infection, and hypothyroidism, had 1Seresto Small Dog collar (Flumethrin-Imidacloprid) placed around the neck by the owner. The dog was also being administered oclcitinib and ketoconazole for his concomitant medical conditions.

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

Shih Tzu/Maltese Crossbreed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

9

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Bleeding
  • General
    • Symptom - Neoplasia

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

An unspecified amount of time post application, in approximately 2014, the dog had application site bleeding and the collar was removed. On an unknown date post collar removal, in approximately 2014, the application site bleeding resolved. Follow up received on 2014-10-20. No further information is expected. This case is closed. Follow up received on 02nd Mar 2017: On an unspecified date in approximately 2014, a 14 year old, 9 pound, neutered, female, Shih Tzu/Maltese crossbred canine, in fair condition, with concomitant alopecia, pruritus, atopy, a fungal skin infection, and hypothyroidism, administered oclcitinib and ketoconazole, had 1 Seresto Small Dog collar (Flumethrin-Imidacloprid) placed around the neck by the owner. An unspecified amount of time post application, in approximately 2014, the dog had application site bleeding and the collar was removed. On an unspecified date, in 2014, the dog was diagnosed with squamos cell carcinoma. On an unspecified date post diagnosis, in 2014, the dog died. It is unknown if a necropsy was performed. The caller contacted Bayer Animal Health to inquire about product use and not to report this event. No further information is expected. 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

Transient mild application site disorders may occur in particularly sensitive animals shortly after product application. However, the described application site bleeding is not expected with product use. Scratching/selftrauma may have contributed to signs. The reported squamous cell carcinoma and death are not expected following appropriate topical product application as inconsistent with products pharmaco-toxicological profile. Oral exposure to the collar is not expected to cause such 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. Animal involved in this case was geriatric, which may have further contributed to the serious signs. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after collar removal (almost after 2 years). Moreover owner does not believe in product connection either as the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Even though some information (e.g. exact time to onset and necropsy report) is not available, sufficient information exists to rule out product relation considering serious outcome of the case. Finally, a product relation is unlikely.