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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-3609

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0033914 (Report 575930)

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.

24-JUN-19

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

10-JUN-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 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 19-Jun-2019, an 8 year old, 37 pound, intact, female, Collie - Border dog, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the animal 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Border Collie

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

16.8

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 / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Edema
    • Specify - Facial and application site
  • Eye
    • Symptom - Edema
    • Symptom - Other
    • Specify - unable to blink
  • Skin
    • Symptom - Lesion
    • Specify - Abscess NOS
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Bloody vomit

12. How long did the symptoms last?

Unknown / Inconnu

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

Approximately 30 minutes post application, the dog exhibited application site swelling, facial swelling, swelling around the eyes, and was unable to blink. The Seresto and identification collars were removed from the dog, then alternating warm and cold compresses were applied to the swollen areas. Approximately 1 hour post application, the swelling ruptured, then blood and discharge were drained. The dog was evaluated by a veterinarian, then started on an unspecified pain medication and unspecified antibiotics. The owner cleaned the ruptured area and applied fish oil to it. On 22-Jun-2019, the dog was anorexic. On 24-Jun-2019, the dog exhibited hematemesis and died. No known 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 application site swelling and facial swelling are in line with a hypersensitivity reaction however product has very low allergic potential. But allergic reactions are possible to any product. No alternative cause described. Swelling around the eyes and unable to blink are likely associated with allergic reaction. Abscess is not expected after product administration. Further reported anorexia is an unspecific and may have numerous other causes. Hematemesis and death are not expected either after collar application as inconsistent with product's pharmacological profile. No oral product exposure reported. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing 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 though time to onset is short for initial reported signs but later reported signs were occurred after collar removal. Other unrelated causes must be considered in this case. Considering the product profile, product involvement is deemed unlikely regarding serious signs, and other causes were considered more likely, however due to limited information (regarding state of health, medical history and necropsy are unknown), a relation to this case is considered as unassessable.