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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1401

2. Registrant Information.

Registrant Reference Number: 1-31809283

Registrant Name (Full Legal Name no abbreviations): WELLMARK INTERNATIONAL

Address: 100 STONE ROAD WEST, SUITE 111

City: GUELPH

Prov / State: ON

Country: CANADA

Postal Code: N1G 5L3

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

Human

4. Date registrant was first informed of the incident.

16-OCT-12

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

02-SEP-12

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. 2724-462-270

Product Name: Adams Flea and Tick Mist for Cats with Precor

Active Ingredient(s)
- (S)-METHOPRENE
  - Guarantee/concentration .1 %
- N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
  - Guarantee/concentration .62 %
- PIPERONYL BUTOXIDE
  - Guarantee/concentration .37 %
- PYRETHRINS
  - Guarantee/concentration .2 %

7. b) Type of formulation.

Liquid

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).

Caller's husband was using product over a period of a couple of months. Caller is unsure of exact date of use.

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

3. List all symptoms, using the selections below.

System

Gastrointestinal System
- Symptom - Anorexia
- Symptom - Weight loss

Skin
- Symptom - Pruritus

Nervous and Muscular Systems
- Symptom - Other
- Specify - can not lay down
- Symptom - Insomnia

Liver
- Symptom - Hyperbilirubinemia
- Specify - bilirubin increase
- Symptom - Hepatic failure
- Specify - failure/dysfunction

Skin
- Symptom - Discolouration
- Specify - color alteration

Liver
- Symptom - Other
- Specify - gallstones

4. How long did the symptoms last?

>1 mo and <= 2mos / >1 mois et < = 2mois

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

Yes

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Non-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.

Unknown

11. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

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's husband was using the product over a period of a couple of months, caller believes he became symptomatic around September 2nd 2012. He has been seen by a doctor and treated for gall stones and some gall stones were removed. His bilirubin was 27.7 and after removal of gall stones increased to 37. He has had CT's and MRIs of his liver. It seems fine. A liver biopsy was done, no results provided. Blood work was done but could not determine what was wrong with him. Doctor stated his condition may be related to his supplements (fish oil, vitamin d, multiple vitamin, Coenzyme Q10) or his new cholesterol medication.

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Incident Report

Subform I: General Information

1. Report Type.

2. Registrant Information.

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

4. Date registrant was first informed of the incident.

5. Location of incident.

6. Date incident was first observed.

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.

7. b) Type of formulation.

Application Information

8. Product was applied?

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?

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

1. Source of Report.

2. Demographic information of data subject

3. List all symptoms, using the selections below.

4. How long did the symptoms last?

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

6. a) Was the person hospitalized?

6. b) For how long?

7. Exposure scenario

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

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

10. Route(s) of exposure.

11. What was the length of exposure?

12. Time between exposure and onset of symptoms.

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.)

To be determined by Registrant

14. Severity classification.

15. Provide supplemental information here.