Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0726

2. Registrant Information.

Registrant Reference Number: 2016-071485

Registrant Name (Full Legal Name no abbreviations): Bayer Inc. Consumer Care

Address: 2920 Matheson Blvd East

City: Mississauga

Prov / State: Ontario

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.

12-APR-16

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

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. Unknown

Product Name: diethyltoluamide (DEET) - containing insect repellent

• Active Ingredient(s)
  • DEET (N,N-DIETHYL-M-TOLUAMIDE) PLUS RELATED ACTIVE TOLUAMIDES (ORTHO & PARA ISOMERS)

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Personal use / Usage personnel

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

A (age) year-old female bridge inspector presented with allergic reaction to diethyltoluamide (DEET) - containing insect repellent. She had prior use without difficulty. In 2013, she used the insect repellent and with only a small amount making contact with her forehead, she had immediate pruritus and erythema on her forehead, persisting for an hour. The following week, she used a different insect repellent and sprayed her face and body.

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.

Medical Professional

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 - Erythema
  • Symptom - Pruritus
  • Symptom - Hives

• Eye
  • Symptom - Other
  • Specify - Angioedema

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

Unknown

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)

Unknown

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

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.)

Case Report: This case report from CANADA was derived from medical literature. A (age) year-old female bridge inspector presented with allergic reaction to diethyltoluamide (DEET) - containing insect repellent. She had prior use without difficulty. In 2013, she used the insect repellent and with only a small amount making contact with her forehead, she had immediate pruritus and erythema on her forehead, persisting for an hour. The following week, she used a different insect repellent and sprayed her face and body. Within minutes, she became diffusely pruritic with generalized urticaria and angioedema of her eyes. She called 911 and was given intramuscular diphenhydramine. Her symptoms gradually eased and she was subsequently well. Her regular medications include venlafaxine and ketorolac. She has no history of atopy. Since the reaction, she has been avoiding all forms of insect repellent, including riding in separate vehicles as her co-workers who use insect repellent. She carries an epinephrine device at all times. Skin testing was performed using two DEET-containing insect repellents: (name) Bug Spray (23.75% DEET) and OFF Family CareBug Spray (5% DEET). She had positive skin prick test to both insect repellents, more prominent with the higher containing DEET repellent. There was also a significant reaction on the skin adjacent to the test site where the repellent had not made contact. She developed significant pruritus and was treated with oral anti-histamine. She had appropriate controls. A control subject tested in the office was negative to both insect repellents. Report source Literature: Literature #1: (name). Severe allergic reaction to diethyltoluamide (DEET) containing insect repellent. Allergy,Asthma, and Clinical Immunology. 2014;10[suppl 2] A30:1

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

The exact product name is unknown, the trade name of a Bayer product was not reported.