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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-2689

2. Registrant Information.

Registrant Reference Number: PROSAR 1-22516131

Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Corporation

Address: 400 Plaza Drive

City: Secaucus

Prov / State: New Jersey

Country: USA

Postal Code: 07094-3688

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

Human

4. Date registrant was first informed of the incident.

06-MAY-10

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW MEXICO

6. Date incident was first observed.

05-MAY-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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-125

Product Name: UltraGuard Flea and Tick Spray for Dogs

  • Active Ingredient(s)
    • TETRACHLORVINPHOS
      • Guarantee/concentration 1.08 %

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).

The patient was exposed to multiple products 24-48 hours prior to the onset of symptoms. On 5/3/10, she was exposed to multiple industrial pesticides while cleaning out dog kennels at her workplace. The following day (5/4), the patient was exposed to a strong epoxy glue smell all day while assisting her father in applying tile flooring. Later in the day on 5/4, the patient bathed her dog (product unknown) and then applied the Tetrachlorvinphos-based spray, rubbing the spray into the dog┐s coat with her hands. The reporter did not know if the patient had washed her hands afterwards. The reporter believed the product was dry before the patient went to bed with the dog. Symptoms developed the following morning (5/5/10).

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: Female

Age: >12 <=19 yrs / >12 <=19 ans

3. List all symptoms, using the selections below.

System

  • Nervous and Muscular Systems
    • Symptom - Seizure

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

Unknown

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

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

>2 hrs <=8 hrs / > 2 h < = 8 h

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.)

1-22516131: The reporter called the registrant on 5/6/10 to report an adverse reaction by a (age) year old girl after she was exposed to a flea and tick spray containing the active ingredient Tetrachlorvinphos. According to the reporter (the patient┐s grandmother), the patient was exposed to multiple products 24-48 hours prior to the onset of symptoms. On 5/3/10, she was exposed to multiple industrial pesticides while cleaning out dog kennels at her workplace. The following day (5/4), the patient was exposed to a strong epoxy glue smell all day while assisting her father in applying tile flooring. Later in the day on 5/4, the patient bathed her dog (product unknown) and then applied the Tetrachlorvinphos-based spray, rubbing the spray into the dog┐s coat with her hands. The reporter did not know if the patient had washed her hands afterwards. The reporter believed the product was dry before the patient went to bed with the dog. The following morning (5/5), the patient awoke and had a seizure. An ambulance took the patient to the hospital to be evaluated; she was released from the hospital and then experienced another seizure. At the time of the call the patient had returned to the hospital, and the attending physicians were calling the episodes "seizures". A diagnosis was still open. During the call the safety profile of the product was discussed. A recommendation was made to continue to work with the physicians. Overexposure to a more concentrated form of the active ingredient could cause neurological symptoms; however, the low concentration in the product (1.08%) and the brief dermal exposure would not be expected to cause anything more significant than minor dermal irritation. The reporter requested and was faxed an MSDS for the product. She indicated her granddaughter had used the Hartz product for years without any problems. A follow-up call on 5/9/10 revealed that the patient had been released from the hospital and was doing much better. No additional seizures had developed. The cause of the seizures was still in question; the family was waiting for results of some blood tests. No additional information is available.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

The patient was exposed to multiple products 24-48 hours prior to the onset of symptoms. On 5/3/10, she was exposed to multiple industrial pesticides while cleaning out dog kennels at her workplace. The following day (5/4), the patient was exposed to a strong epoxy glue smell all day while assisting her father in applying tile flooring. Later in the day on 5/4, the patient bathed her dog (product unknown) and then applied the Tetrachlorvinphos-based spray, rubbing the spray into the dog┐s coat with her hands. The reporter did not know if the patient had washed her hands afterwards. The reporter believed the product was dry before the patient went to bed with the dog. Symptoms developed the following morning (5/5/10).