Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-6296

2. Registrant Information.

Registrant Reference Number: 2015KP302

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.

19-OCT-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

02-JUL-15

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 - 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 approximately 12-Jun-2015, a 2 year old, 62 pound, neutered, male, German Shepherd Dog canine, in good condition with no known concomitant medical conditions, had 1 Seresto Large Dog (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

Other

2. Type of animal affected

Dog / Chien

3. Breed

German Shepherd

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

62

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Hyperthermia

• Blood
  • Symptom - Leukocytosis

• Gastrointestinal System
  • Symptom - Foaming at mouth

• Nervous and Muscular Systems
  • Symptom - Disorientation

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia

• Nervous and Muscular Systems
  • Symptom - Seizure

• Gastrointestinal System
  • Symptom - Vomiting

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?

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 3-Jul-2015, the dog was disoriented, lethargic, anorexic, adipsic and was having seizure like activity. The dog was examined by an emergency veterinarian and was febrile (105.2). The collar was removed, the dog was admitted and bloodwork was performed. The dog had an elevated white blood cell count. The dog was placed on intravenous fluids and was cooled down in an unspecified manner due to the high body temperature. The dog continued to have seizures. On 4-Jul-2015, the dog was given an unspecified type of sedation. The seizures stopped. Approximately 6 hours post administration of the sedative the dog died. A necropsy was not performed. No further information is expected. Case is closed. Follow up received on 6th Jun 2015:On 3-Jul-2015, the dog was disoriented, lethargic, anorexic, adipsic and was having seizure like activity (chewing gum fits). The dog was examined by an emergency veterinarian and was febrile (105.2). The collar was removed, the dog was admitted and bloodwork was performed. The dog had an elevated white blood cell count. The dog was placed on intravenous fluids, an unspecified dose of vitamin B complex and was cooled down in an unspecified manner due to the high body temperature. The dog had a seizure (chewing gum fits) stopped spontaneously. On 4-Jul-2015, the dog started vomiting. The dog was given an unspecified dose of maropitant citrate. Approximately 3 hours post administration of the maropitant citrate, the dog started having a seizure (chewing gum fits). Approximately 7 hours after this seizure episode started, the dog was given an unspecified type of sedation and kept sedated to control seizure activity. Approximately 1 hour post administration of the sedative, the dog was found dead. A necropsy was not performed. No further 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

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 death either. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Furthermore the product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as 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, seizures are not expected. Merely gastrointestinal signs would be possible. However, no oral exposure to product reported. Other reported signs, foaming, disorientation, lethargy, anorexia and adipsia may have occurred due to seizures. Reported signs, febrile and and elevated white blood cell count are not expected after product application as signs are not in line with products pharmaco-toxicological profile. Signs rather be related to other, e.g. infectious cause or intoxication. Vomiting is unspecific sign and may have numerous other causes as well or may be consequence of other signs. Time to onset is too long for all signs and product was tolerated without any problems for more than 3 weeks before first signs were reported. Sudden appearance of serious signs and especially death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Furthermore dog died after sedation, thus other causes must be considered first. Considering the known product profile and time to onset, sufficient information exists to conclude that the product did not cause the event and product involvement was ruled out.