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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2020-2328
2. Registrant Information.
Registrant Reference Number: 2019-US-030107, 2019-US-033260, 2019-US-033261
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.
01-NOV-195. Location of incident.
Country: UNITED STATES
Prov / State: TEXAS
6. Date incident was first observed.
25-OCT-19Product 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. 2596-153
Product Name: Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs
- Active Ingredient(s)
- D-PHENOTHRIN
- Guarantee/concentration .27 %
- D-PHENOTHRIN
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?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Pointer (Unspecified)
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
0.25
7. Weight (provide a range if necessary )
Unknown
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
- 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 24-Oct-2019, 7 out of 8, 3 month old, Pointer (Unspecified) dogs, of unknown weight and mixed sex (3 male, 4 female), in unknown condition, with concomitant medical condition of fleas, were administered 1 application of Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs (Phenothrin) via the topical route by the animal owner. This was extra label use as the product is not intended for use on dogs under 6 months of age. On 25-Oct-2019, one puppy died. All 7 puppies who were administered the product, died within 1 week post administration. No additional clinical signs were exhibited by any of the puppies prior to their death. The one puppy that was not administered the product, remained asymptomatic. The puppies were not evaluated by a veterinarian and no treatments were performed. 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: The product was misused in this case as the puppies were younger than the labeled age of 6 month. Even in the event of misuse, death is not expected. The active ingredient is present in low concentration and is poorly absorbed across intact skin. It is unknown if the puppies had any health issues, beyond the presence of fleas, prior to use. No veterinary care occurred and no necropsy was performed so the cause of death is unknown. Other causes should also be considered including severe flea bite anemia, infectious diseases, toxin exposure, and congenital conditions. 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.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Pointer (Unspecified)
4. Number of animals affected
6
5. Sex
Male
Female
6. Age (provide a range if necessary )
0.25
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
>3 days <=1 wk / >3 jours <=1 sem
11. List all symptoms
System
- 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 24-Oct-2019, 7 out of 8, 3 month old, Pointer (Unspecified) dogs, of unknown weight and mixed sex (3 male, 4 female), in unknown condition, with concomitant medical condition of fleas, were administered 1 application of Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs (Phenothrin) via the topical route by the animal owner. This was extra label use as the product is not intended for use on dogs under 6 months of age. On 28-Oct-2019, 3 puppies died. All 7 puppies who were administered the product, died within 1 week post administration. No additional clinical signs were exhibited by any of the puppies prior to their death. The one puppy that had not been administered the product, remained asymptomatic. The puppies were not evaluated by a veterinarian and no treatments were performed. 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: The product was misused in this case as the puppies were younger than the labeled age of 6 month. Even in the event of misuse, death is not expected. The active ingredient is present in low concentration and is poorly absorbed across intact skin. It is unknown if the puppies had any health issues, beyond the presence of fleas, prior to use. No veterinary care occurred and no necropsy was performed so the cause of death is unknown. Other causes should also be considered including severe flea bite anemia, infectious diseases, toxin exposure, and congenital conditions. 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.
