Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1248

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0006293 (Report 472649)

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.

27-FEB-18

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-143

Product Name: K9 AdvantixII small dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .44 %

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: K9 Advantix II unspecified

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 8.8 %
  • PERMETHRIN
    • Guarantee/concentration 44 %
  • PYRIPROXYFEN
    • Guarantee/concentration .44 %

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-128

Product Name: Advantage II Small Dog

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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7. b) Type of formulation.

Other (specify)

Spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

Units: mL

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 unspecified date in approximately May 2017, a X year old, woman, in unknown condition, with a concomitant medical condition of dry eye, was exposed to unknown amounts of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen), Advantage II Small Dog (Imidacloprid-Pyriproxyfen) and K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) when she was exposed to the dogs for 4 days, while at her mother's house, who had the product applied in an unspecified date in approximately 2017. No known direct contact occurred.

To be determined by Registrant

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

Unknown

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: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Cardiovascular System
  • Symptom - Palpitations

• General
  • Symptom - Edema
  • Symptom - Other
  • Specify - Allergies

• Ear
  • Symptom - Other
  • Specify - Ear infection

• Respiratory System
  • Symptom - Chest congestion
  • Symptom - Wheezing

• Gastrointestinal System
  • Symptom - Diarrhea
  • Specify - Increased bowel movements

• Nervous and Muscular Systems
  • Symptom - Dizziness

• General
  • Symptom - Other
  • Specify - Hypersensitivity - heat sensitivity

• Eye
  • Symptom - Itchy eye

• Respiratory System
  • Symptom - Irritated nose

• Gastrointestinal System
  • Symptom - Nausea

• Nervous and Muscular Systems
  • Symptom - Numbness
  • Symptom - Trembling

4. How long did the symptoms last?

>6 mos / > 6 mois

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

Yes

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)

Contact with treated area

Amount of time between application and contact 4

Day(s) / Jour(s)

What was the activity? The woman was exposed to the dogs for 4 days, while at her mother's house, who had the product applied in an unspecified date in approximately 2017.

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

Unknown

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

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.)

On an unspecified date post exposure, in approximately 2017, the individual traveled to Florida and exhibited increased bowel movements, dizziness, heat sensitivity, itchy eyes, an itchy nose and nausea. On an unspecified date in approximately Jul 2017, the individual was examined by a physician and started on metronidazole. On an unspecified date in approximately Dec 2017, the individual experienced numbness in the toes on her left foot, tremors in her neck, palpitations and edema in her face and ankles. The individual was examined at a health center. It was determined the individual had allergies, an ear infection and chest congestion. The individual was advised to reduce salt intake and started on an unspecified antibiotic. On an unspecified date in approximately Feb 2018, the individual experienced wheezing. On approximately 21 Feb 2018, the palpitations resolved. The individual 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.

Advantix: N-Unlikely: Unclear if indirect exposure to product occurred. Person was just reported to be in the same house as treated pet. Would not expect increased bowel movements, dizziness, heat sensitivity, itchy eyes and nose, and nausea after being in same house as treated pet. Signs were reported when traveling, and likely associated with that (e.g. exposure to air-conditioning in airplane/train/car, motion sickness). Unknown time to onset. Later reported numbness, tremors, palpitations and edema associated with diagnosed allergies, ear infection and chest congestion. Time to onset is too long (7 months). Further reported wheezing is unexpected and occurred 9 months after being in the house with treated pet. Despite time to onset not clear for initially reported signs, considering all aspects, a product relation is deemed unlikely. Initial assessment confirmed by medical doctor. Advantage: N-Unlikely: Unclear if indirect exposure to product occurred. Person was just reported to be in the same house as treated pet. Would not expect increased bowel movements, dizziness, heat sensitivity, itchy eyes and nose, and nausea after being in same house as treated pet. Signs were reported when traveling, and likely associated with that (e.g. exposure to air-conditioning in airplane/train/car, motion sickness). Unknown time to onset. Later reported numbness, tremors, palpitations and edema associated with diagnosed allergies, ear infection and chest congestion. Time to onset is too long (7 months). Further reported wheezing is unexpected and occurred 9 months after being in the house with treated pet. Despite time to onset not clear for initially reported signs, considering all aspects, a product relation is deemed unlikely. Preliminary assessment. Pending the final assessment after evaluation by medical doctor. If assessment is changed, the final statement will be submitted.