Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6731

2. Registrant Information.

Registrant Reference Number: 1257905

Registrant Name (Full Legal Name no abbreviations): Reckitt Benckiser Inc.

Address: 399 Interpace Parkway

City: Parsippany

Prov / State: NJ

Country: USA

Postal Code: 07054

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

Human

4. Date registrant was first informed of the incident.

03-OCT-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

30-SEP-13

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. 30284      PMRA Submission No.       EPA Registration No.

Product Name: LYSOL Fabric Mist Mountain Rain 6/800ML

• Active Ingredient(s)
  • DIDECYL DIMETHYL AMMONIUM CHLORIDE

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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: Res. - In Home / Rés. - à l'int. maison

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

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

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: >6 <=12 yrs / > 6 < = 12 ans

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Edema

• Skin
  • Symptom - Erythema
  • Symptom - Irritated skin
  • Symptom - Itchy skin
  • Symptom - Rash
  • Symptom - Pruritus

4. How long did the symptoms last?

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

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 4

Hour(s) / Heure(s)

What was the activity? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

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

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

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.)

October 3, 2013: Caller reports that he sprayed product over the beds of his 2 sons on Sunday 9/29/2013. A few hours later the children came home and went to bed. They both awoke the following morning with a red rash (red spots) on their faces. He brought one son, (name), whose sxs were worse in for medical eval on Monday 9/30/2013 and he was prescribed oral Prednisone. Caller was also applying Calamine lotion to the affected areas on both children. Prednisone and cream were not helping and the rash has seem to spread and worsen (caller has discontinued use of the Calamine lotion as he did not wish to further irritate the skin). The red spots on their faces are now swollen and the red rash has spread to their stomachs and is also on their genitals (caller is estimating about 30 % of their body has the rash). They are both very pruritic. He is taking them back for a medical evaluation. Follow up completed on 10/8/2013: Caller states both children went back to school yesterday as their rash has started to clear up. Caller states he brought the children to the MD and they were given Prednisone. A cause for this rash has not been determined.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

The differential diagnosis for a skin or allergic condition of this nature includes multiple potential etiologies which, in addition to this product include such factors as plant allergens, poison ivy, poison oak, food, medications, dietary supplements, household soaps, skin care products, infectious pathogens, heat exposure, insect bites, etc. Targeted allergy testing would be required before concluding that this product may be the causative agent.

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: >6 <=12 yrs / > 6 < = 12 ans

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Edema

• Skin
  • Symptom - Erythema
  • Symptom - Irritated skin
  • Symptom - Itchy skin
  • Symptom - Rash
  • Symptom - Pruritus

4. How long did the symptoms last?

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

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 4

Hour(s) / Heure(s)

What was the activity? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

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

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

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.)

October 3, 2013: Caller reports that he sprayed product over the beds of his 2 sons on Sunday 9/29/2013. A few hours later the children came home and went to bed. They both awoke the following morning with a red rash (red spots) on their faces. He brought one son, (name), whose sxs were worse in for medical eval on Monday 9/30/2013 and he was prescribed oral Prednisone. Caller was also applying Calamine lotion to the affected areas on both children. Prednisone and cream were not helping and the rash has seem to spread and worsen (caller has discontinued use of the Calamine lotion as he did not wish to further irritate the skin). The red spots on their faces are now swollen and the red rash has spread to their stomachs and is also on their genitals (caller is estimating about 30 % of their body has the rash). They are both very pruritic. He is taking them back for a medical evaluation. Follow up completed on 10/8/2013: Caller states both children went back to school yesterday as their rash has started to clear up. Caller states he brought the children to the MD and they were given Prednisone. A cause for this rash has not been determined.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

The differential diagnosis for a skin or allergic condition of this nature includes multiple potential etiologies which, in addition to this product include such factors as plant allergens, poison ivy, poison oak, food, medications, dietary supplements, household soaps, skin care products, infectious pathogens, heat exposure, insect bites, etc. Targeted allergy testing would be required before concluding that this product may be the causative agent.