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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-6555
2. Registrant Information.
Registrant Reference Number: 2023-US-18387, 18399, 18401, and 18402
Registrant Name (Full Legal Name no abbreviations): Wellmark International
Address: 100 Stone Road West, Suite 111
City: Guelph
Prov / State: Ontario
Country: Canada
Postal Code: N1G 5L3
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
08-JUN-235. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
06-JUN-23Product 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. 1021-2684-89459
Product Name: Zodiac Flea and Tick Dip For Dogs and Cats
- Active Ingredient(s)
- PIPERONYL BUTOXIDE
- Guarantee/concentration 3 %
- PYRETHRINS
- Guarantee/concentration .3 %
- PIPERONYL BUTOXIDE
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?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Pit Bull Terrier
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.5
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Bloody diarrhea
- General
- Symptom - Lethargy
- Gastrointestinal System
- Symptom - Anorexia
- 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 05 Jun 2023 the animal owner diluted 4 oz of the product with 1 gallon of water and sprayed the product topically on the dog. On 06 Jun 2023, the dog developed vomiting, bloody diarrhea, lethargy, and not eating (anorexia). On 07 Jun 2023, the dog died. Caller suspected the puppies had parvovirus. No further information is expected.
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 has a wide margin of safety and the severe symptoms reported, including death, are not expected following labelled use. If ingested, GI irritation leading to increased salivation, vomiting and diarrhea may occur; if GI signs do develop they are typically mild and self-limiting. Other causes for the dogas symptoms should be considered including infection (such as parvovirus as suspected by the animal owner or other infection), underlying parasites, underlying nutritional deficiencies, and toxic exposure. Veterinary examination and diagnostics including necropsy may have been able to provide further information about the cause of the clinical signs and death, but these were not pursued. 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.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Pit Bull
4. Number of animals affected
3
5. Sex
Male
6. Age (provide a range if necessary )
0.5
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
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Bloody diarrhea
- General
- Symptom - Lethargy
- Gastrointestinal System
- Symptom - Anorexia
- 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 05 Jun 2023 the animal owner diluted 4 oz of the product with 1 gallon of water and sprayed the product topically on the dogs. The dogs were 6 months of age and a mix of male and female puppies. On 07 Jun 2023, these three dogs developed vomiting, bloody diarrhea, lethargy, and not eating (anorexia). On approximately 11 Jun 2023, the dogs were administered an oral pyrantel pamoate product. On 11 Jun 2023, the dogs died. Caller suspected the puppies had parvovirus. No further information is expected.
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 has a wide margin of safety and the severe symptoms reported, including death, are not expected following labelled use. If ingested, GI irritation leading to increased salivation, vomiting and diarrhea may occur; if GI signs do develop they are typically mild and self-limiting. Other causes for the dogas symptoms should be considered including infection (such as parvovirus as suspected by the animal owner or other infection), underlying parasites, underlying nutritional deficiencies, and toxic exposure. Veterinary examination and diagnostics including necropsy may have been able to provide further information about the cause of the clinical signs and death, but these were not pursued. 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.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Pit bull
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.5
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
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Anorexia
- Symptom - Bloody diarrhea
- Symptom - Vomiting
- General
- Symptom - Death
- Symptom - Lethargy
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 05 Jun 2023 the animal owner diluted 4 oz of the product with 1 gallon of water and sprayed the product topically on the dogs. The dogs were 6 months of age and a mix of male and female puppies. On 07 Jun 2023, these three dogs developed vomiting, bloody diarrhea, lethargy, and not eating (anorexia). On approximately 11 Jun 2023, the dogs were administered an oral pyrantel pamoate product. On 11 Jun 2023, the dogs died. Caller suspected the puppies had parvovirus. No further information is expected.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Not Applicable
