Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1249

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0006294 (Report 472651)

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.

30-MAR-17

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. 11556-141

Product Name: K9 Advantix II 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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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-Mar-2017, a X year old, woman, in unknown condition, with concomitant medical conditions of undifferentiated tissue disorder (auto immune disorder NOS), migraine headaches and dry eye, administered prednisone and sumatriptan since approximately 2017, was exposed to an unknown amount of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) and an unknown amount of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) when she applied it to her dogs. On approximately 20-Apr-2017, the individual was exposed to an unknown amount of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) and an unknown amount of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) when she applied it to her dogs. On approximately 20-May-2017, the individual was exposed to an unknown amount of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) and an unknown amount of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) when she applied it to her dogs. On approximately 20-Jun-2017, the individual was exposed to an unknown amount of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) and an unknown amount of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) when she applied it to her dogs. On approximately 20-Jul-2017, the individual was exposed to an unknown amount of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) and an unknown amount of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) when she applied it to her dogs.

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

• Nervous and Muscular Systems
  • Symptom - Trembling

• Skin
  • Symptom - Erythema

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Burning sensation in both arms and legs and on the face

• General
  • Symptom - Edema

• Skin
  • Symptom - Cyanosis

• Respiratory System
  • Symptom - Shortness of breath

• General
  • Symptom - Other
  • Specify - Allergic reaction

• Renal System
  • Symptom - Other
  • Specify - Ketones in urine

• Gastrointestinal System
  • Symptom - Other
  • Specify - Clostridium difficile (disorder of gastrointestinal flora)

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Feeling anxious

• Gastrointestinal System
  • Symptom - Nausea
  • Symptom - Bloating
  • Symptom - Diarrhea

• Skin
  • Symptom - Other
  • Specify - Pimples

• Eye
  • Symptom - Blurred vision
  • Symptom - Double vision

• Skin
  • Symptom - Dermatitis

4. How long did the symptoms last?

Unknown / Inconnu

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 10

Day(s) / Jour(s)

What was the activity? The woman was exposed to the products when she applied it to her 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?

>1 mo <= 6 mos / > 1 mois < = 6 mois

12. Time between exposure and onset of symptoms.

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

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 approximately 30-Mar-2017, the individual experienced anxiety, nausea, bloating, increased bowel movements and diarrhea all intermittently. On an unspecified date in Apr-2017, the individual experienced pimples localized around the mouth, blurry vision and double vision when she watched television. The individual was examined by a dermatologist, was diagnosed with perioral dermatitis and started on hydrocortisone cream. On an unspecified date post onset, in approximately Apr-2017, the pimples resolved and the hydrocortisone was discontinued. On an unspecified date post discontinuation of the hydrocortisone, in approximately 2017, the pimples around the mouth reoccurred. On an unspecified date in approximately May-2017, the individual experienced tremors, erythema, facial erythema (red face), facial edema and a burning sensation in both arms and legs and on the face.On 16-Jun-2017, the individual was examined by a gastroenterologist who performed a fecal and unspecified bloodwork with unknown results. She was started on ondansetron, loperamide and colestipol. On an unspecified date in approximately Jul-2017, the individual experienced cyanotic fingers and lips (poor peripheral circulation), shortness of breath (abnormal breathing), edema with continued erythema and tremors. She was examined by a physician, then the thyroid was checked and a giardia test was performed, both with negative results. It was determined the individual had an allergic reaction and was told to continue the prednisone. Approximately 2 days post exam in Jul 2017, the individual was re-examined and started on metronidazole. On an unspecified date in approximately Aug-2017, the individual was examined by an emergency room physician and a computed tomography scan, bloodwork and a urinalysis were performed. The urinalysis revealed keytones (urine abnormalities NOS) and the individual was administered intravenous fluids. The individual was then examined by a gastroenterologist who performed unspecified tests. It was determined the individual had Clostridium difficile (disorder of gastrointestinal flora) and was started on an unspecified antibiotic. On an unspecified date in approximately Oct-2017, the individual was examined by an infectious disease physician and the individual was started on an unspecified antibiotic. On an unspecified date in approximately Nov-2017, the individual was re-examined by the infectious disease physician no known treatments were provided. On an unspecified date in approximately Feb-2018, the clinical signs improved but continued.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Advantix: N-Unlikely: Unknown if direct or indirect exposure occurred when applying products to dogs. Reported digestive disorders are not expected after exposure to product. Time to onset is long. Moreover, no hand to mouth transfer reported. Anxiety may be associated with other reported signs. Further reported pimples localized around the mouth, blurry vision, double vision, perioral dermatitis are not anticipated after product exposure. Other causes are more probable. Further reported tremor, erythema, facial erythema, facial oedema, burning sensation in arms, legs and face, cyanotic fingers and lips, ketone bodies in urine and disorder of gastrointestinal flora on subsequent product applications are not expected either after product exposure. Moreover, signs are reported long time after each application, hence product relation can be ruled out. Finally, considering all aspects, a product connection is deemed to be unlikely. Initial assessment/causality confirmed by Medical Doctor.