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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-6699

2. Registrant Information.

Registrant Reference Number: 3116363

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.

Address: 160 Quarry Park Boulevard SE Suite 130

City: CALGARY

Prov / State: AB

Country: Canada

Postal Code: T2C 3G3

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

16-NOV-21

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

10-NOV-21

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. 32524      PMRA Submission No.       EPA Registration No.

Product Name: TEMPRID SC INSECTICIDE

  • Active Ingredient(s)
    • BETA-CYFLUTHRIN
    • IMIDACLOPRID

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - In Home / Rés. - à l'int. maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

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.

Data Subject

2. Demographic information of data subject

Sex: Male

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • General
    • Symptom - Edema
  • Skin
    • Symptom - Erythema
    • Symptom - Hives
  • General
    • Symptom - Swelling

4. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

6. a) Was the person hospitalized?

No

6. b) For how long?

Unknown

7. Exposure scenario

Non-occupational

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

What was the activity? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

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.

Unknown

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

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.)

11/16/2021 Caller reports that a pest control operator applied the product in his home 6 days ago. Caller was not home during the application, and returned home after the recommended time frame. He sat in his recliner fully clothed. The next day, caller developed hives on his arms and legs. A few days later, he developed swelling on his feet, ankles, hands, and face. He has been taking an antihistamine, which has helped. Caller mentioned that 7 days before the product was used in his home, he had a flu shot which was against his doctor's recommendation since he had just had a COVID vaccine.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

While a temporal relationship exists between being around the applied product and the onset of symptoms, the product was dry at the time of exposure and very little to no exposure would be expected. All other differential diagnoses have not been ruled out.