Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2817

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2020-US0032867

Registrant Name (Full Legal Name no abbreviations): Bayer Inc. ( Bayer HealthCare LLC ( United States of America) )

Address: x

City: x

Prov / State: x

Country: x

Postal Code: X

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

Human

4. Date registrant was first informed of the incident.

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

04-JUL-20

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. 33691      PMRA Submission No.       EPA Registration No.

Product Name: Clean-Up II Pour-On Insecticide with IGR (US-labeled)

• Active Ingredient(s)
  • DIFLUBENZURON
  • PERMETHRIN

---

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 03-Jul-2020, a x year old woman, in unknown condition, with concomitant medical conditions of a poison ivy allergy, hypothyroidism, and glaucoma, taking levothyroxine sodium, latanoprost, and omeprazole since approximately 2020, was exposed to an unknown amount of Clean Up II Pour-On (Permethrin-Diflubenzuron) when she applied 30 mL to a rag, then rubbed it on her horses while wearing gloves. No known direct exposure 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

• Skin
  • Symptom - Rash
  • Symptom - Blister
  • Symptom - Other
  • Specify - dermat cysts
  • Symptom - Discolouration

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)

Application

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

Chemical resistant gloves

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

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 04-Jul-2020, the individual developed a raised rash and skin discoloration on her forehead, fluid-filled bumps on her hands (dermal cysts), and blistering around the groin area. The individual began taking diphenhydramine and applying hydrocortisone, but was not evaluated by a physician. The signs continued.

To be determined by Registrant

14. Severity classification.

15. Provide supplemental information here.