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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0922

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0001298 (Report 467307)

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

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

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

Domestic Animal

4. Date registrant was first informed of the incident.

15-JAN-18

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

06-DEC-17

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 Small Dog

  • 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 05-Dec-2017, an 8 year old, 15.8 pound, neutered, male, Shih Tzu canine, in unknown condition, with concomitant medical conditions of hypothyroidism and seizures, administered unspecified doses of thyroid medication and phenobarbital since 2016, had 1 Seresto Small 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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

7.167

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Cardiovascular System
    • Symptom - Heart murmur
  • Respiratory System
    • Symptom - Coughing
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • Respiratory System
    • Symptom - Laboured breathing
  • General
    • Symptom - Vocalizing
  • Cardiovascular System
    • Symptom - Other
    • Specify - Weak pulse
    • Symptom - Other
    • Specify - Cardiac enlargement
  • Respiratory System
    • Symptom - Respiratory congestion
  • General
    • Symptom - Other
    • Specify - Abnormal test result

12. How long did the symptoms last?

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

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 6-Dec-2017, the dog exhibited coughing. On 11-Dec-2017, the dog was examined by the veterinarian and exhibited lethargy, anorexia, labored breathing, vocalization, weak pulses, and grade 3/6 heart murmur. Radiographs revealed cardiac enlargement and pulmonary congestion. An in house blood profile showed alkaline phosphatase was elevated at 216 IUL (abnormal test result). The collar was removed. On 12-Dec-2017, the dog was started on unspecified doses of furosemide and benazepril. On 26-Dec-2017, the dog died at home; a necropsy was not performed. No further information is expected; 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

O-Unassesssable: Initially reported coughing is not expected after appropriate application of the collar. Later reported labored breathing, vocalization, weak pulses and grade 3/6 heart murmur are not expected either. Further, reported lethargy, anorexia and vocalization are unspecific. However, these signs likely associated to diagnosed cardiac enlargement and pulmonary congestion. Elevated alkaline phosphatase and death are not expected following appropriate topical product application as inconsistent with product真真真s pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. Other causes are likely, e.g. respiratory disease, cardiac disease resulting in pulmonary congestion. Time to onset is short for coughing while it is long for later reported signs. Though reported signs are not in line with product真真真s known safety profile, due to time to onset, product involvement is considered as unassessable.