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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0567

2. Registrant Information.

Registrant Reference Number: 2017KP070

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.

27-JAN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

06-OCT-16

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 - Large 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 an unknown date in 2016, a 3 year old, 55 pound,neutered female, Retriever (Golden) canine, in good condition, with no known concomitant medical conditions, had1 Seresto Large Dog collar (Flumethrin-Imidacloprid) 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

Golden Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

55

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Edema
    • Specify - Application site oedema
  • Respiratory System
    • Symptom - Other
    • Specify - Pulmonary congestion
    • Symptom - Other
    • Specify - Pulmonary haemorrhage
    • Symptom - Pulmonary edema
    • Symptom - Respiratory failure
  • General
    • Symptom - Other
    • Specify - Abnormal test result - abnormal necropsy finding

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

On 06 Oct 2016, the dog was found deceased with the collar tight around the neck and the neck was edematous. There was no evidence the collar had been caught on a structure; however part of the collar was pushed back through the first loop with the excess forming a circular shape between both collar loops. The collar was cut off the dog. No known necropsy was performed. Follow up received on 27th Oct 2016: On 12 Oct 2016, a necropsy was performed by a commercial laboratory. On gross necropsy exam, there was prominent dirt in and around the mouth, the stomach and intestines were autolytic, the pancreas was congested, the liver was markedly congested, the pharyngeal and laryngeal areas were hyperemic and had mild edema, there was marked pulmonary hemorrhage, edema and congestion, bilateral renal congestion, and mild cerebrovascular congestion. The histopathology results matched the gross results. Most of the tissue changes were mild and nonspecific. The likely cause of death was the marked pulmonary edema, pulmonary congestion and pulmonary hemorrhage, which indicate noncardiogenic respiratory failure of unknown cause. 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

Reported signs, application site oedema and death are not expected with product use. Death in this case was possibly due to strangulation as part of the collar was pushed back through the first loop with the excess forming a circular shape between both collar loops resulting in tightening of the collar. Reported signs may be the result of inappropriate collar position however unknown how the collar tightened. Although it was described that the collar was correctly applied, it is not fully clear. The collar should not tighten when it is applied properly. Alternative causes cannot be ruled out (e.g. trauma of other origin). The likely cause of death was the marked pulmonary edema, pulmonary congestion and pulmonary hemorrhage, which indicate noncardiogenic respiratory failure. Overall a product involvement is considered possible.