Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1250

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0006295 (Report 472653)

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)

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-141

Product Name: K9 Advantix II small dog

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

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-125

Product Name: Advantage II Medium Dog

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

---

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 %

---

7. b) Type of formulation.

Other (specify)

Spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: pipette

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 approximately 20-Jun-2017, a X year old, man, in unknown condition, with concomitant medical conditions of type II diabetes, hypertension and high cholesterol, was exposed to an unknown amount of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) and K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) when it was applied to the dogs. No known direct contact occurred. On approximately 20-Jul-2017, the individual was exposed to an unknown amount of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) and K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) when it was applied to the dogs. No known direct contact occurred. On 27-Nov-2017, the individual was exposed to an unknown amount of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) and Advantage II Medium Dog (Imidacloprid-Pyriproxyfen) when it was applied to the dogs. No known direct contact occurred. On 31-Dec-2017 the individual was exposed to an unknown amount of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) and Advantage II Medium Dog (Imidacloprid-Pyriproxyfen) when it was applied to the dogs. 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: Male

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

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Red skin
  • Symptom - Other
  • Specify - Acne

• Gastrointestinal System
  • Symptom - Other
  • Specify - Flatulance
  • Symptom - Vomiting
  • Symptom - Diarrhea
  • Symptom - Nausea

4. How long did the symptoms last?

>6 mos / > 6 mois

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)

Contact with treated area

What was the activity? The man was exposed to the products when it was applied to the dogs

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.

Skin

11. What was the length of exposure?

>6 mos <=1 yr / > 6 mois < = 1 an

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 Jul-2017, the individual experienced facial erythema and acne on his face, upper arms and back. On an unspecified date in approximately Aug-2017, the individual experienced intermittent times of increased bowel movements with intermittent flatulence. On an unspecified date post exposure, in approximately Dec-2017, the individual experienced vomiting and diarrhea; both clinical signs resolved in approximately 5 minutes. On an unspecified date post exposure, in approximately Jan-2018, the individual experienced nausea and vomited once; the vomiting resolved in approximately 5 minutes. The nausea resolved approximately 8 hours post onset. The individual was not examined by a physician and the facial erythema and acne on his face, upper arms and back , intermittent bowel movements and intermittent gas continued.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Advantix: N-Unlikely: Suspected accidental indirect exposure. Contact with treated dog. Affected areas not typically affected in case of exposure to product while applying on dog or when touching recently treated dog. Would rather expect hands or arms to react. Facial erythema and acne on face, arms and back are not expected. Later reported digestive signs observed after further applications are not anticipated after product exposure. Irritation and/or numbness would be the first symptoms in case of exposure to mouth. No oral exposure reported. Though the duration between product exposure and onset of signs is unknown, it seems too long (10+ days). Moreover signs continued for rather long duration. Other causes are likely. Considering overall aspects, a product connection is deemed to be unlikely. Preliminary assessment. Pending the final assessment after evaluation by Medical Doctor. If assessment is changed, the final statement will be submitted. Advantage: N-Unlikely: Suspected accidental indirect exposure. Contact with treated dog. Reported skin disorders, increased bowel movements and flatulence were reported before product exposure, therefore not product related. Later reported vomiting, diarrhea and nausea are not anticipated after product exposure. No oral exposure reported. Considering that exposure scenario is unclear and that duration between product exposure and onset of signs seems too long after every application (10+ days), a product connection is deemed to be unlikely. Preliminary assessment. Pending the final assessment after evaluation by medical doctor. If assessment is changed, the final statement will be submitted.