Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2010-1615

2. Registrant Information.

Registrant Reference Number: 01-10-22202503

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.

09-APR-10

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

23-MAR-10

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. 25739      PMRA Submission No.       EPA Registration No. 2724-401

Product Name: Vet Kem Siphotrol Plus Pump Spray for Homes

• Active Ingredient(s)
  • (S)-METHOPRENE
  • PERMETHRIN

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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).

Premise product was sprayed on the perimeter of the floor and between the mattresses in the caller's father's room.

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: Male

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Paralysis

• Respiratory System
  • Symptom - Pneumonia

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Chemical taste in mouth
  • Symptom - Death

• Respiratory System
  • Symptom - Other
  • Specify - scarring of the lung tissue

4. How long did the symptoms last?

Persisted until death

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

18

Day(s) / Jour(s)

7. Exposure scenario

Non-occupational

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

Contact with treated area

What was the activity? re-entry

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

Respiratory

11. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

12. Time between exposure and onset of symptoms.

>24 hrs <=3 days / >24 h <=3 jours

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.)

The product was applied to the perimeter of the room and between the mattresses on March 20th or 21st. The caller's father said he could taste the product after application. He slept on the treated bed overnight. On March 23rd, the elderly man was hospitalized. He has a history of diabetes and chronic obstructive pulmonary disease. The man was on 4 different antibiotics and other medications. The caller's father died on April 9th.

To be determined by Registrant

14. Severity classification.

Death

15. Provide supplemental information here.

Product identification was not verified.The caller stated she "did not have the product with her but she thinks this is the product". Inappropriate use of product:Mattresses are not a labeled use site for this product.Caller stated her father slept in the bed the night of the application contrary to her instructions to him.Caller further stated her father partially closed the window after application.No additional information was provided regarding treatment of the premises to determine whether there was compliance with label directions as they relate to the re-entry time frame or proper ventilation of treated area after application.The Prosar specialist told the caller that it was not believed that the product is the cause of the father's symptoms.Once the product is dry it is safe.Adverse health effects from contact with the wet product are typically limited to the upper respiratory tract and resolve without affecting other body functions.Typically once the patient is removed from the source of the vapors and placed into an area with fresh air, those symptoms would resolve.The severity, duration of the symptoms, and the outcome (death) are not consistent with short term (acute) low level exposure to permethrin or S-methoprene. S-Methoprene is essentially non-toxic.Irritation of the skin, eyes and upper respiratory tract are associated with permethrin exposure.Headaches and vomiting as well as asthma-like symptoms have been reported in sensitive individuals.Symptoms are short lived once the source is removed.The (age) year old male was not in good health and had been previously diagnosed with chronic obstructive pulmonary disease.The scarring of the lung tissue, muscle paralysis and onset of pneumonia reported in this case are not symptoms associated with acute low level exposure to permethrin.Permethrin has low vapor pressure and inhalation exposure would not be expected unless there was direct contact with product during application.

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

1. Source of Report.

Data Subject

2. Demographic information of data subject

Sex: Female

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

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Bronchitis

• General
  • Symptom - Pain

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)

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

Respiratory

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 opened the windows in the room and sprayed the product on March 20th or 21st. There were no symptoms while spraying the product. The caller has a history of asthma and treatment/medication for blood pressure problems. The caller uses medications: Advair 250, Ventolin rescue inhaler, and Benicar blood pressure medication. The caller was taking antibiotics Biaxion and Cipro for her illnesses.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

Product identification was not verified.The caller stated she "did not have the product with her but she thinks this is the product".Inappropriate use of product: Mattresses are not a labeled use site for this product.Caller further stated her father partially closed the window after application.No additional information was provided regarding treatment of the premises to determine whether there was compliance with label directions as they relate to the re-entry time frame or proper ventilation of treated area after application.The Prosar specialist told the caller that if the product was wet and inhaled, it could cause upper respiratory irritation and symptoms such as coughing might occur.Once the product was dry, we would not anticipate anything else to occur.Patients who smoke or have underlying respiratory conditions may experience more pronounced symptoms that require medical attention.Inhalers or nebulizer therapy indicated for acute respiratory symptoms may be used in the prescribed manner as symptoms dictate.Symptoms should resolve when area is ventilated and spray has dried.