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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-2958

2. Registrant Information.

Registrant Reference Number: PROSAR Case # 1-26621657

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.

Domestic Animal

4. Date registrant was first informed of the incident.

27-JUN-11

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

27-JUN-11

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. 2596-62

Product Name: Hartz in control 5 month flea and tick collar

  • Active Ingredient(s)
    • TETRACHLORVINPHOS
      • Guarantee/concentration 14.55 %

7. b) Type of formulation.

Other (specify)

collar

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).

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Bulldog

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.23

7. Weight (provide a range if necessary )

14

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Muscle tremors
  • Respiratory System
    • Symptom - Pulmonary edema
  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Vomiting
  • Eye
    • Symptom - Miosis
  • Gastrointestinal System
    • Symptom - Salivating excessively
    • Symptom - Other
    • Specify - rectal prolapse
  • Respiratory System
    • Symptom - Coughing
    • Specify - "coughing up some of the phlegm"
    • Symptom - Respiratory failure
    • Symptom - Tachypnea
  • Nervous and Muscular Systems
    • Symptom - Difficulty getting up
    • Symptom - Other
    • Specify - "semi-conscious"
  • Skin
    • Symptom - Hives
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1-26621657- The reporter, a veterinarian, indicates a patient may have been exposed to a product containing the active ingredient tetrachlorvinphos. The reporter indicated a twelve week fourteen pound male bulldog had presented to him for an elective ophthalmic procedure. The dog was asymptomatic on presentation but within 45 minutes of presentation the animal developed respiratory distress, seizures, twitching, hypersalivation, vomiting, and diarrhea leading to rectal prolapse, pulmonary edema, pin point pupils and respiratory distress. The reporter indicates the pet owner had placed the product, a flea and tick collar, six days prior to the animal¿s presentation. The caller had initiated manual CPR and administered diazepam, atropine, and the animal was intubated. The reporter indicated within the past hour the animal had coughed up phlegm, began breathing o its own and remained semi conscious and tachypnic. The caller was advised the symptoms seen would be unexpected following use as labeled. He was advised to seek other etiology. The caller was advised of care that may be offered following inappropriate use or ingestion, and offered a prognosis. On follow up the next day the veterinarian indicated the animal¿s status was unchanged. He had continued supportive care but had not looked into other potential causes for the animal¿s illness. The pet owners had concerns about cost of care and were considering euthanasia. New and additional signs seen included generalized hives for which the veterinarian had administered diphenhydramine. It was reiterated to the caller to seek other diagnosis. He was supplied with submission information for registrant supported cholinesterase testing and for registrant supported necropsy. On yet one additional call back the veterinarian had stated the animal had died two days following his initial report. It was unclear if the practitioner would submit the animal for necropsy or cholinesterase test samples. No further information is available.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here