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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6475

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0062124 (Report 528968)

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.

15-OCT-18

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

15-JUL-18

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 Cat

  • 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).

On approximately 04-Apr-2018, a 16 year old, feline with unknown signalment and condition, with no known concomitant medical conditions, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar 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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

16

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
  • Skin
    • Symptom - Itchy skin
  • General
    • Symptom - Other
    • Specify - Lack of efficacy
    • Symptom - Parasitism
    • Specify - Fleas

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 15-Jul-2018, the cat exhibited pruritus and fleas were seen. On an unknown date in approximately Jul-2018, the cat died due to unknown circumstances. In is unknown if a necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss the use of Seresto in her current pets and not to report the death of the patient. No further 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 SLEE/fleas. Pruritus is not expected with appropriate topical product use. If any, it would be located at the application site of the collar. Pruritus in this case rather associated with current flea infestation. However, presence of fleas is not a sign of inefficacy. Product is not a repellent. Fleas have to be on the animal to come into contact with the product to be killed. Fleas were reported after a flea-free time. Sudden appearance of fleas after flea-free time suggests re-infestation with fleas from environment (e.g. other untreated pets, wildlife). This may lead to new establishment of a flea population in pet's environment requiring several weeks of treatment to disappear. Further, reported death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious sign either. Moreover, the reason for the phone call was to discuss the use of product in her current pets and not to report the death of the patient. Time to onset is long. Other causes are more probable in this geriatric cat. Overall, a product relation is considered unassessable.