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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5410

2. Registrant Information.

Registrant Reference Number: 1-53957398

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

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.

13-SEP-18

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

Unknown

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. 2724-490

Product Name: Precor 2000 Plus Premise Spray

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .85 %
    • D-PHENOTHRIN
      • Guarantee/concentration .3 %
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration 2 %
    • PERMETHRIN
      • Guarantee/concentration .35 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 1.75 %

7. b) Type of formulation.

Other (specify)

Aerosol

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).

At an unknown date the caller had PCO spray the product around the house to treat flea infestation and ten days later she had PCO re-apply treatment.

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.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Other
    • Specify - Squamous Cell Carcinoma

4. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

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)

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 stated that her dog had bad fleas and that she had fleas all over her socks and presumed flea bites on her leg. She had a PCO employee spray the product around the house to help with flea infestation in June. She continued to get bites/ sores on her leg, so she had the PCO employee come back and re-apply the product ten days later. She continued to have bites on her leg that were not healing so she went to the doctor. Her doctor believed the poor healing was due to her diabetes. The sores continued and then started to scab over. She went to the dermatologist and they took samples. They diagnosed the scabs and squamous cell carcinoma. She wanted to know if this could be related to the product. The call center staff stated this product contains a very low concentration of pyrethroid insecticides, which have a wide margin of safety and a low level of toxicity. Call center staff stated skin exposure may cause burning, itching, tingling or a numbness sensation, symptoms would typically develop soon after the exposure and resolve spontaneously within 24 hours. Call center staff also stated per the SDS, Permethrin was determined to be non-mutagenic in several studies, since the scabs were there prior to the use of product it would not likely be related to the symptoms she was experiencing or the diagnosis of squamous carcinoma. Call center staff said to have her physician call back with any additional questions or concerns.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Call center staff said it is doubtful that the product was related to causing the clinical situation.