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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-5935

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0056900 (Report 600266)

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.

23-SEP-19

5. Location of incident.

Country: UNITED STATES

Prov / State: CONNECTICUT

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 Collar unknown

  • 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 unknown date in 2015, an 8 year old, female, Schnauzer (Miniature) canine, of unknown weight, reproductive status, and condition, with concomitant medical conditions of periodic lethargy, comedones, skin staph infection, and chronic pancreatitis, administered diphenhydramine since 2013, had one Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. The collar remained on the dog for 8 months, then was removed on an unknown date in 2015.

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

Miniature Schnauzer

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>6 mos <=1 yr / > 6 mois < = 1 an

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Blood
    • Symptom - Other
    • Specify - Abnormal blood work
  • General
    • Symptom - Neoplasia
  • Renal System
    • Symptom - Renal failure
  • General
    • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

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 unknown date in 2016, the canine had one Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner that remained on for approximately 8 months and was then removed in 2016. On an unknown date in 2016, the 11 year old canine was examined and diagnosed with cancer on the side of her head. It was unknown if any treatments were performed. On an unknown date in 2019, the canine had one Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unknown date in 2019, the 14 year old canine was examined by a veterinarian and diagnosed with kidney failure. The canine was treated with enalapril and sotalol. On approximately 12-Aug-2019, the canine died and it was unknown if a necropsy was performed. No further 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

N - Unlikely 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. 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 and also thereafter. 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. Time to onset is unknown. Abnormal blood results and diagnosed cancer are not expected after product application. Other causes are more probable. Further, diagnosed kidney failure and fatal outcome of death are not expected, either. In this case of geriatric animal, fatal outcome was the consequence of alternative causes (cancer and kidney failure) and thus, sufficient information exists to rule out product involvement. Most of the signs were reported after collar removal. Moreover, time to onset for kidney failure and death was unknown after subsequent collar application. Considering overall aspects product involvement is unlikely.