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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5459

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0044174 (Report 510215)

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.

04-AUG-18

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

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)

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

Product Name: Seresto (unspecified)

  • 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 an unspecified date in approximately Apr 2018, a 10 year old, 19 pound, intact, male, Boston Terrier canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto (unspecified) (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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Boston Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

8.62

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Renal System
    • Symptom - Frequent urination
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Pacing
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Vomiting

12. How long did the symptoms last?

Persisted until death

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 approximately 2018, the dog exhibited intermittent vomiting. On 13-Jul-2018, the dog was anesthetized by an attending veterinarian with dental extractions and a dental prophylaxis were performed. The dog was started on an unspecified dose of tramadol by mouth daily. On 16-Jul-2018, the dog exhibited a seizure which resolved in approximately 1 minute. The owner contacted the veterinarian and the dog was started on a regimen of gabapentin by mouth daily. It was unknown if the dog was examined. On 17-Jul-2018, the dog exhibited a seizure. The seizure resolved in approximately 1 minute. The owner contacted the veterinarian but the dog was not examined and no known treatments were performed. On 28-Jul-2018, the dog exhibited a seizure which resolved in approximately 1 minute. The dog was examined by a veterinarian and started on a regimen of phenobarbital by mouth daily. On 29-Jul-2018, the dog exhibited increased urination. On 30-Jul-2018, the dog exhibited cluster seizures. The dog was examined by a veterinarian, no known treatments were performed. The cluster seizures resolved approximately 30 minutes post onset. On 31-Jul-2018, the dog exhibited circling and pacing. On approximately 01-Aug-2018, the dog exhibited recumbency, so the dog was administered phenobarbital and prednisone. The dog was then examined by a veterinarian and administered diazepam by injection. Approximately 1 hour post administration of diazepam, the dog died. No necropsy was performed. No more information is expected; this 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 - Unclassifiable/unassessable Reported vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Time to onset is unknown in this case. 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. But seizures were reported in connection with product use in dogs and were requested by authorities to be content of the EU SPC. However, it is known that overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies for a 6 months period did not cause serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Other causes are more likely. Increase in urination, circling, pacing and recumbency are not expected and may rather be associated with the seizures. Death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Sign in this case may be a consequence of the underlying medical conditions. Time to onset is long. Considering chronology, product relation remains unassessable.