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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-5205

2. Registrant Information.

Registrant Reference Number: 2016CK202

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.

Human

4. Date registrant was first informed of the incident.

18-JUL-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

19-DEC-15

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

  • 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 12-Jun-2016, a (age) year old woman, was exposed to an unknown amount of 1 Seresto SmallDog (Flumethrin-Imidacloprid) Collar when the dog slept inher bed with her after the product had been applied.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Female

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Eye
    • Symptom - Swollen eye
  • Respiratory System
    • Symptom - Difficulty Breathing
  • Gastrointestinal System
    • Symptom - Other
    • Specify - oedema inside mouth
  • Skin
    • Symptom - Other
    • Specify - facial swelling

4. How long did the symptoms last?

Unknown / Inconnu

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

No

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Other

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

12. Time between exposure and onset of symptoms.

>8 hrs <=24 hrs / > 8 h < = 24 h

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

On 13-jun-2016 the lady had shortness of breath, oedema NOS (inside of mouth), facial swelling and eye swelling. the lady was not examined by a physician and the clinical signs continued

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

O - Unclassifiable/unassessable. No direct product exposure reported but indirect exposureoccurred to the product as person slept with treated dogin the same bed. Site of exposure is unclear since theowner slept with the dog and hence exposure to theproduct is bound to happen on any parts of the body.Respiratory tract disorders or eye disorders are notexpected. The collar is odorless. Thus, disturbance by thecollars smell is unlikely. The product is not volatile atroom temperature and inhalation therefore not possible.No eye exposure reported. Hypersensitivity reactions tothe collar are not typically seen however may occur withdirect product exposure and respective disposition.Reported oedema inside of mouth is not expected withappropriate product use as not consistent with product spharmacological profile. No oral product exposurereported. Further the owner was in poor condition andreported to have concomitant medical history of allergies,hypertension, shortness of breath, nervous systemdisorder (Restless Leg Syndrome), anxiety, heart failure,pulmonary disease, diabetes which may have contributedto the signs. Time to onset is short though. However, asvarious other causes are likely, product involvement isdeemed to be unassessable.