Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-0391

2. Registrant Information.

Registrant Reference Number: 2020-US-037210

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.

16-OCT-20

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

16-SEP-20

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.       PMRA Submission No.       EPA Registration No. 2596-153

Product Name: Hartz UltraGuard Rid Flea and Tick Shampoo with Oatmeal for Dogs

• Active Ingredient(s)
  • D-PHENOTHRIN
    • Guarantee/concentration .27 %

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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).

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

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

4

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Skin
  • Symptom - Irritated skin

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

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 approximately 16-Sep-2020, a 13 year old, approximately 4 pound, unknown, female, Chihuahua dog, in unknown condition, with no known concomitant medical condition, was administered 1 application of Hartz UltraGuard Rid Flea and Tick Shampoo with Oatmeal for Dogs (Phenothrin (Sumithrin)) via the topical route by the animal owner. Immediately post application, the dog developed skin irritation on a unspecified location. On 09-Oct-2020, the dog developed lethargy and multiple episodes of vomiting. No treatments were performed, the dog was not evaluated by a veterinarian, and the signs continued. On 11-Oct-2020, the dog died. It is unknown if a necropsy was performed. The animal owner has used unspecified Hartz products for many years without issue. It is unknown if this specific product had previously been applied to the dog. No further information was received.

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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 a pyrethroid insecticide in very low concentration and thus has a wide margin of safety in dogs. Delayed onset vomiting and lethargy progressing to death is not anticipated following use. Other causes should be considered in this case including GI foreign body obstruction, GI disease, pancreatitis, metabolic disease, and cancer. Without veterinary evaluation and diagnostics including necropsy, the cause of death remains unknown. 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.