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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0728

2. Registrant Information.

Registrant Reference Number: 170176057

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: N1G5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

09-OCT-17

5. Location of incident.

Country: UNITED STATES

Prov / State: SOUTH DAKOTA

6. Date incident was first observed.

04-OCT-17

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.       PMRA Submission No.       EPA Registration No. 2724-485-270

Product Name: Adams Plus Flea And Tick Shampoo For Cats Kittens Dogs And Puppies

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .1 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 1.5 %
    • PYRETHRINS
      • Guarantee/concentration .15 %

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).

On October 3, 2017 the owner inappropriately bathed the dog with a large amount of the product to treat a condition.

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

Japanese Chin

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6.0

7. Weight (provide a range if necessary )

8.3

lbs

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
  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Depression
  • General
    • Symptom - Hypothermia
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Recumbent
    • Specify - Inability to Stand
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

2.5

Hour(s) / Heure(s)

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 October 4, 2017, the dog had an isolated event of vomiting and developed lethargy and depression. A couple of hours later, the dog had another isolated event of vomiting. On the evening on October 5, 2017 the owner took the dog to the regular veterinarian who stated the dog had developed hypothermia with a temperature of 94.6 degrees Fahrenheit (F), anorexia, and was unable to stand. Shortly after, the regular veterinarian provided fluid therapy. Later in the evening, the regular veterinarian called the owner stating the dog needed to be euthanized however, the dog ended up passing away on his own. On October 9, 2017, the owner contacted the Animal Product Safety Service (APSS) and stated that the regular veterinarian performed a necropsy on October 6, 2017 and stated that the product was the cause of death. The APSS veterinarian stated that any dermally applied product can cause skin irritation and/or hypersensitivity reaction, but that systemic signs are not expected as long as product was used according to label directions. The APSS veterinarian further stated that ingestion of small amounts, such as licking fur, might result in a taste reaction and mild gastrointestinal (GI) upset. The APSS veterinarian also stated that the product should not have caused the death of the dog and the APSS assistant recommended that the owner call back with questions.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. A necropsy was unavailable as the dog had already been sent for cremation. An unlabeled large amount of shampoo was used on the dog, so this was an inappropriate use of the product.