Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-3709

2. Registrant Information.

Registrant Reference Number: 2021-US-017228

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.

04-JUN-21

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

03-JUN-21

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. 2596-84

Product Name: Hartz UltraGuard Flea and Tick Collar for Dogs (non-specific)

• 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).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

8

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Seizure
  • Symptom - Ataxia

• Liver
  • Symptom - Elevated liver enzymes

• Nervous and Muscular Systems
  • Symptom - Head tilt

• Respiratory System
  • Symptom - Dyspnea

• Eye
  • Symptom - Other
  • Specify - Strabismus

• Renal System
  • Symptom - Other
  • Specify - Elevated renal values

• Respiratory System
  • Symptom - Pulmonary edema

• General
  • Symptom - Death
  • Symptom - Abnormal behaviour

• Cardiovascular System
  • Symptom - Other
  • Specify - May have gone into cardiac arrest

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Limp
  • Symptom - Recumbent

• General
  • Symptom - Other
  • Specify - Not mentally appropriate

• Nervous and Muscular Systems
  • Symptom - Muscle twitching

• Respiratory System
  • Symptom - Other
  • Specify - Increased respiratory effort

• Gastrointestinal System
  • Symptom - Salivating excessively

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Non specific neurological signs

• General
  • Symptom - Neoplasia

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?

11

Day(s) / Jour(s)

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

On 02-Jun-2021, a 10 year old, approximately 8 pound, neutered, male, Crossbred dog, in unknown condition, with concomitant medical conditions of cardiac disease, liver disease, tracheal collapse and suspected Cushings disease, was administered 1 collar of Hartz UltraGuard Flea and Tick Collar for Dogs (non-specific) (Tetrachlorvinphos (Rabon)) via the topical route by the animal owner. The dog also received an unknown dose of furosemide via the oral route that was prescribed previously. On 03-Jun-2021, the dog developed seizures and may have gone into cardiac arrest. The animal owner performed cardiopulmonary resuscitation on the dog, removed the collar, and bathed the dog with an unknown amount of unspecified human shampoo. On 04-Jun-2021, the dog was brought to the emergency veterinary facility for evaluation. Upon presentation, the dog exhibited head tilt and circling to the right, strabismus to the right, in the right eye only, went limp, was unable to stand, had two seizures, had slightly elevated liver enzymes and was not mentally appropriate. The dog was admitted to the intensive care unit and was placed on oxygen therapy. The seizures and muscle twitching resolved at a unspecified time after the administration of 3 doses of atropine, and unspecified doses of midazolam, levetiracetam, methocarbamol, and phenobarbital. The veterinarian also noted apparent respiratory concerns and changes to the right lung (pulmonary edema), possibly related to cardiopulmonary resuscitation efforts at home. The dog was also administered butorphanol due to increased respiratory effort. On approximately 07-Jun-2021, the dog had elevated renal values, circling, and dyspnea continued, but showed improvement with the other clinical signs. On 14-Jun-2021, the clinical signs returned and the dog developed hypersalivation, experienced intermittent focal seizures and non-specific neurological signs. On 15-Jun-2021, the dog died. The emergency veterinarian suspected the dog had a brain tumor and that the clinical signs were not likely related to the product. No further information was received in this case.

---

To be determined by Registrant

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

Death

19. Provide supplemental information here

Assessment: This product contains tetrachlorvinphos, an organophosphate insecticide with a good safety margin in dogs. Even if product residue were ingested after application, only mild GI upset would be expected. The severe and progressive signs reported, even after product removal and bathing, are not consistent with the toxicological profile of the product. The treating veterinarian suspected the dog had a brain tumor and also did not think the dog's signs were consistent with organophosphate toxicosis. The information contained in this report is based on self-reported statements provided to the registrant during telephone interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.