Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2255

2. Registrant Information.

Registrant Reference Number: 2019-CA-000016

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.

10-MAY-19

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

03-MAY-19

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. 30731      PMRA Submission No.       EPA Registration No.

Product Name: Hartz UltraGuard Pro Drops for Dogs Over 28 kg Spot-on

• Active Ingredient(s)
  • (S)-METHOPRENE
  • D-PHENOTHRIN

---

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

Dog / Chien

3. Breed

German Shepherd

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.75

7. Weight (provide a range if necessary )

100

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Agitation

• Skin
  • Symptom - Pruritus

• General
  • Symptom - Lethargy

• Skin
  • Symptom - Erythema

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Abnormal behaviour

• Skin
  • Symptom - Rash
  • Specify - bumps

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Fully Recovered / Complètement rétabli

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 03-May-2019, a 9 month old, 100 pound, female, Shepherd Dog - German dog, in unknown condition, with no known concomitant medical condition, was administered 1 tube of Hartz UltraGuard Pro Drops for Dogs Over 28 kg (Phenothrin / S Methoprene) via the topical route by the animal owner. The product was applied between the shoulder blades along the dog's back to the base of the tail. Approximately fifteen seconds post application, the dog developed agitation, application site pruritus and began rolling on the ground. The animal owner wiped the application site using a wet rag and the symptoms slightly improved but continued. Approximately 10 minutes post application, the dog developed lethargy, anorexia and was reluctant to be touched at the application site. The symptoms of lethargy and anorexia resolved approximately 12 hours post onset. On approximately 06-May-2019, the dog allowed the animal owner to touch her and they discovered small, red bumps on the application site. On approximately 10-May-2019, the symptoms resolved and the dog recovered. Bathing with liquid dish soap was discussed as an option if the owner wished to remove the product. Recommended consulting with a veterinarian and discontinue use of the product in the future. No further information was received in this case.

---

To be determined by Registrant

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

Minor

19. Provide supplemental information here

This product has a wide margin of safety but with this active ingredient we can see lethargy, agitation, gastrointestinal upset, and pruritis. 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.