Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3871

2. Registrant Information.

Registrant Reference Number: 2015TH283

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

Address: 2920 Matheson Blvd

City: Mississauga

Prov / State: ON

Country: Canada

Postal Code: L9W 5R6

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

Domestic Animal

4. Date registrant was first informed of the incident.

05-AUG-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

08-OCT-13

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 Collar - cat

• 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).

owner applied collar Aug 31 2013

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 short hair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

8

lbs

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

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Oral hemorrhage

• Skin
  • Symptom - Lesion

• General
  • Symptom - Swelling

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 31 Aug 2013 the cat was now 19 month old and 8 pound, had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 08 Oct 2013 the collar got stuck in the cat's jaw and on an unknown period of time later the cat had mouth bleeding, had facial swelling and lacerations/skin lesions on the face. The collar was removed by the owner and the cat died of unknown causes after 30 minutes. No necropsy was performed.

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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 Reported signs are not expected with appropriate collar administration. However, it may be possible that collar application was too loose. When collar comes in such an inappropriate position, the described reaction may occur. Time to onset consistent. Death, however, is not expected after product application, even not with reported signs in mouth and face. Unkown, why animal died. Death occurred 30 minutes after collar was removed. Although product may have caused reported signs in mouth and face, death is considered unlikely product related. Overall, case assessed as unclassifiable.