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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-3566
2. Registrant Information.
Registrant Reference Number: 2012BS042-US0006201
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
17-APR-125. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
05-MAR-12Product 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. 11556-144
Product Name: K9 Advantix II Extra Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- PYRIPROXYFEN
- Guarantee/concentration .44 %
- IMIDACLOPRID
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
4Units: mL
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 March 4th, 2012,1 tube of K9 Advantix II Extra Lrg Dog was applied to the dorsal midline of a 9 year old, 85 lb, spayed female Lab x golden retriever by owner.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
Other
2. Type of animal affected
Dog / Chien
3. Breed
Lab x Golden Retriever
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
9
7. Weight (provide a range if necessary )
85
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Respiratory System
- Symptom - Panting
- Symptom - Coughing
- Symptom - Difficulty Breathing
- Gastrointestinal System
- Symptom - Retching
- Symptom - Bloody vomit
- General
- Symptom - Lethargy
- Symptom - Death
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
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 March 5, 2012 dog was lethargic, panting, coughing and having difficulty breathing. The evening of Mar 6, 2012, dog was retching. On Mar 7,2012, the dog vomited clear fluid with specks of blood in it. Dog still had a good appetite but no longer begging for table scraps. The dog passed away early morning of Mar 10, 2012 and was never examined by a veterinarian. No necropsy was performed. Evaluation of used batch of product did not reveal a connection between product and observed signs from QA/technical perspective. Concomitant Medical Condition: Unknown.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Although time of onset might suggest relation to product use, signs neither expected nor in line with pharamco-toxicological product profile. Product acting topically. Even misuse of using orally wouldn't lead to this effect. No veterinarian examined dog. Overall other causes are more likely (e.g. foreign body). No connection between product and observed signs. Connection considered unlikely.
