Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4925

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0041300

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.

10-JUL-17

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

09-JUL-17

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 Cat Collar

• 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).

A 2 year old, 8 pound, neutered, male, Domestic Shorthair feline, in good 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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

3.629

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Skin
  • Symptom - Lesion

• Blood
  • Symptom - Thrombocytopenia

• Respiratory System
  • Symptom - Dyspnea

• Nervous and Muscular Systems
  • Symptom - Recumbent

• Gastrointestinal System
  • Symptom - Salivating excessively

• General
  • Symptom - Hemorrhage
  • Symptom - Edema
  • Symptom - Death

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 10-Mar-2017, a 2 year old, 8 pound, neutered, male, Domestic Shorthair feline, in good condition, with no known concomitant medical conditions, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 09-Jul-2017, the cat was found with the collar in his mouth; the collar was removed. The cat was examined by an emergency veterinarian and was laterally recumbent, dsypnic and had lesions present in the corners of the mouth. Bloodwork was performed and revealed thrombocytopenia. The cat was treated with supplemental oxygen. On 10-Jul-2017, the cat was seen by the attending veterinarian; all clinical signs continued. A lateral chest radiograph did not reveal any sufficient finding. No other treatments were performed. Follow up received on 17th Jul 2017: On 10-Mar-2017, a 2 year old, 8 pound, neutered, male, Domestic Shorthair feline, in fair condition, with concomitant medical conditions of eyelid agenesis, blind in right eye and fleas, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 09-Jul-2017, the cat was found with the collar in his mouth; the collar was removed. The cat was hypersalivating, was hemorrhaging from his paws, had facial edema and dyspnea. The cat was examined by an emergency veterinarian and was laterally recumbent, dsypnic and had lesions present in the corners of the mouth. Bloodwork was performed and revealed thrombocytopenia. The cat was treated with supplemental oxygen, intraveneous fluids and an unspecified antibiotic. On 10-Jul-2017, the cat was seen by the attending veterinarian; all clinical signs continued. A lateral chest radiograph did not reveal any sufficient finding. The cat recieved a steroid injection and an unknown medication. The cat was transferred to the emergency clinic for observation through the night. On 11-Jul-2017, the cat passed away. No necropsy was performed. No more information is expected. 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

O - Unclassifiable/unassessable Cat was found with the collar in mouth. Reported lesions present in the corners of the mouth are related to the inappropriate collar position.Although not clearly stated, it is possible that collar application was too loose enabling the pet to move the collar in the inappropriate position. Other signs of hypersalivating may be related to the collar position as well, however hemorrhaging paws, facial edema and dyspnea and later reported recumbency are not expected with the described collar position. Signs may be secondary to the cat having the collar in the mouth and related to cat's agitation and the attempts to remove the collar. However ongoing signs despite collar removal are untypical and rather suggest other underlying conditions. Concurrently diagnosed thrombocytopenia is not expected as inconsistent with pharmaco-toxicological product profile. Death is not expected following appropriate topical product application as inconsistent with products pharmacological 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. Time to onset is consistent for signs associated with collar trapping but it is long for later diagnosed thrombocytopenia and death. No necropsy not performed. Other unrelated causes must be consider in this case. Overall, a product relation is unassessable.