Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-6706

2. Registrant Information.

Registrant Reference Number: 2016KP264

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-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

04-MAR-16

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)

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Collar

• Active Ingredient(s)
  • FLUMETHRIN
  • IMIDACLOPRID
    • Guarantee/concentration 10 %

---

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 01Mar2016, a 4 year old, 4 pound, intact, female, Poodle(Miniature) canine, in good condition, with a heart murmur,was examined by the veterinarian for annual evaluation. The dog was administered a distemper, hepatitis, parvo and parainfluenza combination vaccine, an intranasal bordetella vaccine and an unknown dose of milbemycin oxime/lufenuron by mouth. and a Seresto collar.

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

Miniature Poodle

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

4

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

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

11. List all symptoms

System

• General
  • Symptom - Death

• Cardiovascular System
  • Symptom - Heart murmur

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Lethargy

• Cardiovascular System
  • Symptom - Tachycardia

• General
  • Symptom - Vocalizing

• Nervous and Muscular Systems
  • Symptom - Seizure
  • Symptom - Convulsions
  • Symptom - Trembling
  • Symptom - Other
  • Specify - Motor Dysfunction

• Cardiovascular System
  • Symptom - Cardiac arrest

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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 04Mar2016, the dog became inappetent. The dog was examined by the veterinarian and was administered an unknown dose of dexamethasone sodium phosphate by injection. On 07Mar2016, the inappetence resolved. The owner removed the Seresto collar. On 08Mar2016, the dog became lethargic. On 09Mar2016, the inappetence recurred and the dog exhibited tachycardia, and vocalization. The dog was examined by the veterinarian and was exhibiting seizures, trembling, and decreased motor function. The cardiac murmur had increased in severity. Prior to any diagnostics, the dog went into cardiac arrest and died. No necropsy was performed. The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. No more information is expected and the case is closed.

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Inappetence is unspecific and may have numerous causes. Time to onset is short, but several vaccines applied as well. All further reported other signs occurred two days after removal of collar thus not product related. Time to onset is long. The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Animal has concomitant history of cardiac murmur which is suggestive of other unrelated and undiagnosed causes. Considering all clinical signs and chronology, a product relation is unlikely.