Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3903

2. Registrant Information.

Registrant Reference Number: 2015CK272

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

Address: 2920 Matheson Boulevard

City: Missisaugua

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.

05-AUG-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

26-NOV-12

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. 1556-155

Product Name: Seresto Collar - large dog

• 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).

On 25-Nov-2012, a 8 year old, 63.9 pound, intact, female, Boxer canine, in fair condition, with a known medical history of tapeworms and fleas, had a Seresto Dog Large (Flumethrin-Imidacloprid) collar placed topically 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

Dog / Chien

3. Breed

boxer

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

63.9

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Bizarre behaviour
  • Symptom - Seizure

• General
  • 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.

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 26-Nov-2012 the dog began presenting abnormal behavior of "acting funny".On 28-Nov-2012 the dog had a seizure and death occurred. A necropsy is pending. The dog was not examined or treated by a veterinarian.Follow-up, 20 Dec 2012: On 05-Dec-2012 the necropsy showed several foreign in bodies in the dogs stomach and intestine. The abdominal cavity was full of fluid from peritonitis resulting in the death of the dog. It was also discovered that the dog had adenocarcinoma of the intestine along with chondroid and osseous metaplasia.18 Feb 2013: Technical assessment: The complained batch was manufactured and released according to specification. No deviations occurred which lead to the complained AE.

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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

The product is not anticipated to cause seizures or death after appropriate topical product administration, as inconsistent with pharmaco-toxicological product profile. No oral product exposure reported. No neurological signs are expected without oral product uptake. Any action or treatment may trigger seizures in an animal with a respective disposition. Death possibly related to the seizure or other underlying medical condition. Time to onset though close, not indicative for product relation. Necropsy revealed several foreign bodies in stomach and intestine, and peritonitis and adenocarcinoma resulting in the dogs death. Considering this cause for the fatal outcome, product involvement was ruled out for this event.Technical evaluation of used batch did not reveal a connection between product and observed signs from a QA/technical perspective.