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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-3612

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0038712 (Report 505047)

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

16-JUL-18

5. Location of incident.

Country: UNITED STATES

Prov / State: OKLAHOMA

6. Date incident was first observed.

03-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 14-Jun-2018, an Unknown Breed feline, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Cat collar (Flumethrin-Imidacloprid) placed around the neck by the owner. The version number on tin is inconsistent with Bayer Product. This product is suspect counterfeit.

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

Cat / Chat

3. Breed

unknown

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?

>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 - Abnormal behaviour
    • Symptom - Hiding
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Recumbent
    • Specify - Unable to stand
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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 03-Jul-2018 the feline showed a behavior change, hiding, vocalizing, the feline was ataxic and unable to stand. Approximately 3 hours later the feline passed away. No necropsy was performed. BAH comment: Technical assessment was conducted and revealed that the product is suspected to be a counterfeit.


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 The collar was suspected to be a counterfeit, thus the relationship between product and the event cannot be assessed. Nevertheless, reported signs are unspecific and may have numerous other causes. Signs may occur initially after collar administration but are not expected to appear after long time. Moreover, reported neurological signs are not typically seen with appropriate topical product administration. No oral product exposure reported. Even with oral product exposure which was not reported - only transient gastrointestinal signs are expected. Subsequently 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 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset too long. In this case low level of information provided and finally, as suspected counterfeit product used, no final conclusion about product causality can be made and product relation is deemed unassessable.