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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2147

2. Registrant Information.

Registrant Reference Number: 2028574

Registrant Name (Full Legal Name no abbreviations): Lonza

Address: 90 Boroline Road

City: Allendale

Prov / State: New Jersey

Country: U.S.A

Postal Code: 07401

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

Human

4. Date registrant was first informed of the incident.

01-AUG-17

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

26-APR-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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 6836-305-5389

Product Name: ClickSan Disinfectant Cleaner

  • Active Ingredient(s)
    • DIDECYLDIMETHYLAMMONIUM CHLORIDE
    • DIOCTYLDIMETHYLAMMONIUM CHLORIDE
    • N-ALKYL(40% C12, 50% C14, 10% C16)DIMETHYLBENZYLAMMONIUM CHLORIDE
    • OCTYLDECYLDIMETHYLAMMONIUM CHLORIDE

7. b) Type of formulation.

Application Information

8. Product was applied?

Unknown

9. Application Rate.

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

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

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: Unknown

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Cracked skin

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

Unknown

6. a) Was the person hospitalized?

Unknown

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.

Unknown / Inconnu

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.)

Caller had 3 employees complaining of dry cracked skin after putting their hands into the sanitizer. One employee had developed hives in the past and cracked bleeding skin. The hives had resolved at the time of the report.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Unknown

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Cracked skin

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

Unknown

6. a) Was the person hospitalized?

Unknown

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.

Unknown / Inconnu

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.)

Caller had 3 employees complaining of dry cracked skin after putting their hands into the sanitizer. One employee had developed hives in the past and cracked bleeding skin. The hives had resolved at the time of the report.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Unknown

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Cracked skin

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

Unknown

6. a) Was the person hospitalized?

Unknown

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.

Unknown / Inconnu

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.)

Caller had 3 employees complaining of dry cracked skin after putting their hands into the sanitizer. One employee had developed hives in the past and cracked bleeding skin. The hives had resolved at the time of the report.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.