Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-5595
2. Registrant Information.
Registrant Reference Number: 140089596
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.
18-JUL-14
5. Location of incident.
Country: UNITED STATES
Prov / State: MICHIGAN
6. Date incident was first observed.
16-JUL-14
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. 2724-803-270
Product Name: Adams Flea and Tick Spray for Dogs and Cats
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration .1 %
- ETOFENPROX
- Guarantee/concentration .25 %
- PIPERONYL BUTOXIDE
- Guarantee/concentration .75 %
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).
Only July 16, 2014 the owner sprayed the kittens with the product.
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
Tiffany
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.27
7. Weight (provide a range if necessary )
1.0
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 - Trembling
- Symptom - Fasciculations
- General
- Symptom - Pale mucous membrane colour
- Respiratory System
- Symptom - Shortness of breath
- Specify - Shallow breathing
- Symptom - Dyspnea
- Renal System
- Symptom - Inappropriate urination
- Gastrointestinal System
- Symptom - Inappropriate defecation
- Symptom - Anorexia
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 July 16, 2014 shortly after the product was applied the kitten became symptomatic. The owner then rinsed the kitten's coat/skin with water and provided thermoregulation. About an hour later, the kitten developed shallow breathing and dyspnea. On July 17, 2014 the kitten died. On July 18, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated there is risk for a taste reaction or mild gastrointestinal (GI) upset if ingested. The APSS veterinarian also stated she would not expect life-threatening signs or respiratory signs, particularly with appropriate use. A necropsy is not available due to the length of time the kitten as been deceased.
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 GI upset (hypersalivation, vomiting) and trembling may be related, but she would not expect pallor, loss of bowel moments (bm) or urine control, respiratory signs, or death with this product.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Tiffany
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.27
7. Weight (provide a range if necessary )
1.0
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 - Trembling
- Symptom - Fasciculations
- General
- Symptom - Pale mucous membrane colour
- Respiratory System
- Symptom - Shortness of breath
- Specify - Shallow Breathing
- Symptom - Dyspnea
- Renal System
- Symptom - Inappropriate urination
- Gastrointestinal System
- Symptom - Inappropriate defecation
- Symptom - Anorexia
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 July 16, 2014 shortly after the product was applied the kitten became symptomatic. The owner then rinsed the kitten's coat/skin with water and provided thermoregulation. About an hour later, the kitten developed shallow breathing and dyspnea. On July 17, 2014 the kitten died. On July 18, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated there is risk for a taste reaction or mild gastrointestinal (GI) upset if ingested. The APSS veterinarian also stated she would not expect life-threatening signs or respiratory signs, particularly with appropriate use. A necropsy is not available due to the length of time the kitten as been deceased.
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 GI upset (hypersalivation, vomiting) and trembling may be related, but she would not expect pallor, loss of bowel moments (bm) or urine control, respiratory signs, or death with this product.