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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-3170

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0026777 (Report 568166)

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.

31-MAY-19

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

29-MAY-19

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 Large Dog (Flumethrin-Imidacloprid) Collar

  • Active Ingredient(s)
    • FLUMETHRIN
      • Guarantee/concentration 4.5 %
    • 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 29-May-2019, a 5 year old, approximately 180 pound, intact, male, Mastiff 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

Mastiff canine

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

81.647

kg

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

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Head tilt
    • Symptom - Unconsciousness
  • Respiratory System
    • Symptom - Coughing
  • General
    • Symptom - Vocalizing
    • Symptom - Other
    • Specify - Behavioural disorder NOS
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • General
    • Symptom - Death
  • Respiratory System
    • Symptom - Difficulty Breathing
  • General
    • Symptom - Licking
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Gagging
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Shaking

12. How long did the symptoms last?

Unknown / Inconnu

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

Approximately 30 minutes post application, the dog exhibited difficulty breathing on inhalation, lip licking, vomiting foam, coughing, gagging, and vocalization. The dog struggled to stand and was stretching his legs out (behavioral disorder). The collar was removed about 5 minutes after onset of the clinical signs. The dog was bathed with dish washing detergent and the signs resolved. Approximately 45 minutes post application, the dog began shaking for 30 seconds, had ataxia, and had a head tilt to the right. The dog was put in a kennel for observation. Approximately 4 hours post application, the dog recovered. On 30 May 2019, the dog was laterally recumbent and unresponsive when called. The dog was leashed and walked out of his kennel, then acutely died. No necropsy was performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

O - Unclassifiable/unassessable Reported digestive disorders are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility) but mild gastrointestinal signs may occur shortly after product application. Reported respiratory disorders are not expected after collar application and may be associated with digestive disorders. Vocalization is likely related to earlier described signs. Unknown if collar perhaps was fitted to tightly. Reported neurological signs are not typically seen with appropriate topical product administration. Even with oral product exposure which was not reported only transient gastrointestinal signs are expected. Especially serious neurological disorder like unresponsiveness is not expected. Reported behavioural disorder and shaking are likely associated with neurological signs. Further reported lateral recumbency and sudden death are not expected as well following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. Product has wide margin of safety. Signs occurred after removal of collar and bathing of dog. No information medical history and necropsy details provided. Other causes (e.g. an underlying condition, poisoning etc.) must be considered although not described. Time to onset is short. Considering all aspects, a product relation is unassessable.