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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7943

2. Registrant Information.

Registrant Reference Number: 2016KP224

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.

18-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

29-MAR-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)

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

Product Name: Seresto Collar

  • 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 approximately 15Nov2015, a 16 year old, approximately10 pound, neutered, female, Domestic Shorthair feline, in fairc ondition, with concomitant flea allergy dermatitis and fleas,had 1 Seresto Cat Collar (Flumethrin-Imidacloprid) placed around the neck by the owner.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

16

7. Weight (provide a range if necessary )

10

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

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Pruritus
    • Symptom - Dermatitis

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 approximately 29Mar2016, the cat developed generalized pruritus and rash on abdomen. On 12Apr2016 the collar was removed. The cat was not seen by a veterinarian and the clinical signs continued. Follow up received (29th Aug 2016): On an unknown date post collar application, in approximately May-2016, the cat had 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On an unknown date in 2016 the owner used an unknown carpet spray flea treatment. Approximately 3 months post Advantage II Large Cat, in Aug-2016, the cat died. The cat was not examined by a veterinarian and it was unknown if a necropsy had been preformed. No further information expected. This case is closed. Note: Previous exposure was well tolerated by the animal.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Generalized pruritus and rash on abdomen are not expected with topical product administration. If any, skin reactions would be localized at the application site. The animal had a concomitant medical condition of allergic dermatitis which likely contributed to the reported skin reactions. Time to onset is exceptionally long. Reported death is not anticipated after product application as it is inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. Moreover, death occurred long time after collar removal. Animal involved in this case was geriatric with a fair health condition. Also, previous exposure was well tolerated by the animal. Overall, even though no necropsy was performed, considering the known safety profile of the product and the chronology, a product relation is unlikely.