Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4259

2. Registrant Information.

Registrant Reference Number: 2016KP140

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.

18-JUL-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

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 - 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 an unspecified date in 2016, a 5 pound, canine of unknown signalment, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Small Dog Collar (Flumethrin-Imidacloprid) 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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Smooth Fox Terrier

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

5

lbs

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

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Convulsions
  • Symptom - Seizure
  • Symptom - Ataxia
  • Symptom - Abnormal gait
  • Symptom - Other
  • Specify - Musculoskeletal disorder

• Gastrointestinal System
  • Symptom - Salivating excessively

• Renal System
  • Symptom - Inappropriate urination

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

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 an unspecified date post application, in 2016, the dog exhibited seizures. The dog was examined by a veterinarian and it is unknown if any treatments were preformed. Case was entered with limited information provided in the initial e-mail communication. Follow up information received on 13th May 2016 : On 25-Apr-2016, a 6 year old, approximately 5 pound, neutered, female, Fox Terrier canine, in good condition with no known concomitant medical conditions, had 1 Seresto Small Dog Collar (Flumethrin-Imidacloprid) placed around the neck by the owner. On 01May2016 the dog developed hind end ataxia. On 04May2016 the owner removed the collar. On 05May2016 the dog was examined by a veterinarian which diagnosed an abnormal gait on right front paw and spinal injury. The veterinarian prescribed an unspecified dosage of oral prednisone at an unspecified frequency. On 07May2016 the dog had a seizure which was approximately 1 hour in length, hypersalivation, and inappropriate urination. The dog was examined by an emergency veterinarian which placed in an oxygen chamber. It is unknown what treatments were performed. On 08May2016 the dog was prescribed an unspecified dosage of an unspecified seizure medication at an unspecified frequency and discharged to monitor at home by the owner. On 10May2016 the dog had two more seizures and passed away at home. No necropsy was preformed. No further information is expected. This 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

Hind end ataxia is not anticipated with appropriate topical product administration. No oral product exposure reported. Even with oral product exposure only transient gastrointestinal signs but no neurological signs would be expected. Abnormal gait is not expected after topical product application, it is likely due to reported spinal injury. Spinal injury is inconsistent with pharmaco toxicological product profile. The product is not anticipated to cause serious neurological disorders such as seizures and serious sign like death after appropriate topical product administration. The controlled release mechanism assures release of only low doses of active ingredient at a time. Overdose of 5 collars around the neck of 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 did not cause serious signs either. Even with oral product exposure, serious signs are not expected. Other causes are more probable (e.g. idiopathic epilepsy). Reported hypersalivation and inappropriate urination are likely consequence of seizures. Moreover apart from hind limb ataxia all other signs were observed after removal of collar. Considering the known product profile and long time to onset, sufficient information exists to conclude that the product did not cause the event and product involvement is unlikely.