Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2305

2. Registrant Information.

Registrant Reference Number: 2020-CA-000011

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.

21-JAN-20

5. Location of incident.

Country: CANADA

Prov / State: NEW BRUNSWICK

6. Date incident was first observed.

14-JAN-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. 25621      PMRA Submission No.       EPA Registration No. 2596-83

Product Name: Hartz UltraGuard Flea and Tick Collar for Cats and Kittens

• Active Ingredient(s)
  • TETRACHLORVINPHOS

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7. b) Type of formulation.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

8

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Lethargy

• Skin
  • Symptom - Erythema

• Blood
  • Symptom - Bleeding

• Skin
  • Symptom - Pruritus
  • Symptom - Hair loss
  • Symptom - Other
  • Specify - Application site mucopurulent discharge

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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 13-Dec-2019, a 1 year old, 8 pound, intact, female, Domestic Shorthair cat, in unknown condition, with no known concomitant medical conditions, was administered 1 collar of Hartz UltraGuard Flea and Tick Collar for Cats and Kittens (Tetrachlorvinphos) via the topical route by the animal owner. On approximately 14-Jan-2020, the cat developed lethargy and anorexia. On approximately 19-Jan-2020, the cat developed application site pruritus, application site hair loss, application site erythema, application site bleeding, application site mucopurulent discharge and the collar was removed. The animal owner called their veterinarian and was advised to apply over the counter topical antibiotic cream every 8-12 hours for 5 days and if clinical signs persisted beyond 5 days or if the clinical signs worsened, then evaluation was recommended. No further information was received in this case.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Assessment: Dermal reactions may occur following use of any topical product. However, it is unexpected to have signs of this severity occur one month after the collar was applied. Other causes should also be considered including active fleas leading to persistent scratching and skin trauma and acute moist deramitis if the cat was bathed or otherwise got wet and moisture was trapped under the collar. 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 can not 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.