Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2766

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0027423 (Report 492885)

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

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

Human

4. Date registrant was first informed of the incident.

05-JUN-18

5. Location of incident.

Country: UNITED STATES

Prov / State: SOUTH CAROLINA

6. Date incident was first observed.

16-MAR-18

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. 11556-142

Product Name: K9Advantix II Medium Dog

• 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

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 approximately 15 Mar 2018, a x year old, x pound, man, in unknown condition, with concomitant medical conditions of a renal disorder (kidney transplant) and a heart valve disorder, self administered tacrolimus since approximately 2018, was exposed to an unknown amount of K9 Advantix II Medium Dog (Imidacloprid-Permethrin-Pyriproxyfen) when he picked up his dog approximately 5 hours post product application.

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Paresthesia
  • Specify - burning sensation
  • Symptom - Edema
  • Symptom - Erythema
  • Symptom - Rash

• General
  • Symptom - Neoplasia

• Skin
  • Symptom - Other
  • Specify - Shingles

• General
  • Symptom - Other
  • Specify - Abnormal test result

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 24

Hour(s) / Heure(s)

What was the activity? was exposed to an unknown amount of K9 Advantix II Medium Dog (Imidacloprid-Permethrin-Pyriproxyfen) when he picked up his dog approximately 5 hours post product application.

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?

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 approximately 16 Mar 2018, the individual experienced a burning sensation with swelling localized to the left arm, so the individual showered with an unspecified soap. Approximately 30 minutes post showering, the individual experienced erythema and a rash localized to the left arm, so he applied a cold compress to the affected area. On an unspecified date post onset, in approximately 2018, the individual was examined by his primary care physician who looked at the arm and his ear. The physician determined that the individual had a neoplasm on the ear. No known treatments were provided. He was then examined by a dermatologist, who removed the neoplasm from the ear and determined the individual had shingles which had manifested on the left arm. The individual was started on 2 unspecified creams, one was for the ear. On 04-May-2018, the individual had the tacrolimus level checked, which was elevated to 12 (previous level was approximately 6). On approximately 05 Jun 2018, the burning sensation was improved.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

N - Unlikely Accidental indirect exposure. Contact with treated animal, however, unknown if affected site is consistent with exposed site. Burning sensation, erythema and rash may occur in sensitive individual. Reported swelling of left arm and neoplasm of ear are not expected as inconsistent with pharmaco toxicological product profile. Furthermore continuation of signs despite showering not expected. Signs may rather be associated with later diagnosed shingles. Shingles are not expected either. Increase in tacrolimus level is not expected. Though time to onset is consistent for initially reported signs it is rather long for further reported serious signs. Other causes more probable. Considering overall aspects, a product connection is unlikely. Initial assessment/causality confirmed by medical doctor.