Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-1310

2. Registrant Information.

Registrant Reference Number: 2014-CA-00273

Registrant Name (Full Legal Name no abbreviations): Merck Animal Health (Intervet Canada Corp)

Address: 16750 Transcanada Highway

City: Kirkland

Prov / State: Quebec

Country: Canada

Postal Code: H9H 4M7

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

Human

4. Date registrant was first informed of the incident.

03-APR-14

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

01-DEC-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. 27829      PMRA Submission No.       EPA Registration No. 773-74

Product Name: SABER POUR ON

• Active Ingredient(s)
  • LAMBDA-CYHALOTHRIN

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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: 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).

Human symptomatic suspected adverse reaction, accidental exposure(ELU), reported to the company on 03 April 2014. The clinic reported that they provide services to a large feedlot client and has recently switched to Saber Pour On. The staff have used Insecticide products before and no reports of adverse events in the past. There are 3 individuals( 2 males in their (age) and 1 female in her (age)) who work for the feedlot who have indicated that they have experienced some skin reactions (burning/itching sensations) they feel may be associated with the product. Clinic reported that out of 3 staff, who gave the complaints, two of them reported recently and one was received in Dec 2013. None of the workers have sought any medical treatment as a result of their complaints. The workers apply the treatments without the presence of a veterinarian. It is suspected that personal protective equipment(PPE) is not worn(ELU-Treatment program not respected). It was advised to review correct product handling and the use of PPE immediately with the workers. There have been no other complaints. No further information is expected. Update 17 April 2014 Technical Services contacted the reporting veterinarian for follow-up discussion. In addition to the previous report, the vet indicated that the woman had experienced the burning sensation on her face without any direct contact with the product. The skin did not appear red or irritated and did resolve (unknown time). No further information is expected.

To be determined by Registrant

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

No

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 - Burning skin
  • Symptom - Itchy skin

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

Occupational

8. How did exposure occur? (Select all that apply)

Application

Drift from the application site

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?

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.)

Human symptomatic suspected adverse reaction, accidental exposure(ELU), reported to the company on 03 April 2014. The clinic reported that they provide services to a large feedlot client and has recently switched to Saber Pour On. The staff have used Insecticide products before and no reports of adverse events in the past. There are 3 individuals( 2 males in their (age) and 1 female in her age) who work for the feedlot who have indicated that they have experienced some skin reactions (burning/itching sensations) they feel may be associated with the product. Clinic reported that out of 3 staff, who gave the complaints, two of them reported recently and one was received in Dec 2013. None of the workers have sought any medical treatment as a result of their complaints. The workers apply the treatments without the presence of a veterinarian. It is suspected that personal protective equipment(PPE) is not worn(ELU-Treatment program not respected). It was advised to review correct product handling and the use of PPE immediately with the workers. There have been no other complaints. No further information is expected. Update 17 April 2014. Technical Services contacted the reporting veterinarian for follow-up discussion. In addition to the previous report, the vet indicated that the woman had experienced the burning sensation on her face without any direct contact with the product. The skin did not appear red or irritated and did resolve (unknown time). No further information is expected.

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: Male

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Burning skin
  • Symptom - Itchy skin

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

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)

None

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.)

Human symptomatic suspected adverse reaction, accidental exposure(ELU), reported to the company on 03 April 2014. The clinic reported that they provide services to a large feedlot client and has recently switched to Saber Pour On. The staff have used Insecticide products before and no reports of adverse events in the past. There are 3 individuals( 2 males in their (age) and 1 female in her age) who work for the feedlot who have indicated that they have experienced some skin reactions (burning/itching sensations) they feel may be associated with the product. Clinic reported that out of 3 staff, who gave the complaints, two of them reported recently and one was received in Dec 2013. None of the workers have sought any medical treatment as a result of their complaints. The workers apply the treatments without the presence of a veterinarian. It is suspected that personal protective equipment(PPE) is not worn(ELU-Treatment program not respected). It was advised to review correct product handling and the use of PPE immediately with the workers. There have been no other complaints. No further information is expected. Update 17 April 2014 Technical Services contacted the reporting veterinarian for follow-up discussion. In addition to the previous report, the vet indicated that the woman had experienced the burning sensation on her face without any direct contact with the product. The skin did not appear red or irritated and did resolve (unknown time). No further information is expected.

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: Male

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Burning skin
  • Symptom - Itchy skin

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

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)

None

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.)

Human symptomatic suspected adverse reaction, accidental exposure(ELU), reported to the company on 03 April 2014. The clinic reported that they provide services to a large feedlot client and has recently switched to Saber Pour On. The staff have used Insecticide products before and no reports of adverse events in the past. There are 3 individuals( 2 males in their (age) and 1 female in her (age) who work for the feedlot who have indicated that they have experienced some skin reactions (burning/itching sensations) they feel may be associated with the product. Clinic reported that out of 3 staff, who gave the complaints, two of them reported recently and one was received in Dec 2013. None of the workers have sought any medical treatment as a result of their complaints. The workers apply the treatments without the presence of a veterinarian. It is suspected that personal protective equipment(PPE) is not worn(ELU-Treatment program not respected). It was advised to review correct product handling and the use of PPE immediately with the workers. There have been no other complaints. No further information is expected. Update 17 April 2014 Technical Services contacted the reporting veterinarian for follow-up discussion. In addition to the previous report, the vet indicated that the woman had experienced the burning sensation on her face without any direct contact with the product. The skin did not appear red or irritated and did resolve (unknown time). No further information is expected.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.