Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-6443
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2018-US0065432 (Report 532309)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
30-OCT-18
5. Location of incident.
Country: UNITED STATES
Prov / State: RHODE ISLAND
6. Date incident was first observed.
29-OCT-18
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. 11556-144
Product Name: K9advantixII extra large dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- PYRIPROXYFEN
- Guarantee/concentration .44 %
7. b) Type of formulation.
Other (specify)
Spot-on
Application Information
8. Product was applied?
Yes
9. Application Rate.
4
Units: 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 29-Oct-2018, a 9 year old, 125 pound, neutered, male, Crossbred canine, in unknown condition, with concomitant medical conditions of arthritis and no veterinary examination since 25 Sep 2017, was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner.
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
Dog / Chien
3. Breed
Crossbred
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
9
7. Weight (provide a range if necessary )
56.699
kg
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
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- General
- Symptom - Abnormal behaviour
- Respiratory System
- Symptom - Difficulty Breathing
- Nervous and Muscular Systems
- General
- Symptom - Death
- Symptom - Cancer
- Specify - Haemangiosarcoma
- Cardiovascular System
- Symptom - Other
- Specify - Pericardial effusion
- Nervous and Muscular Systems
- Symptom - Other
- Specify - Degenerative joint disease
- Blood
- Symptom -
- Specify - Hyperplasia of the spleen
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
Approximately 1 hour post application, the dog developed an unspecified behavior change.
On 30 Oct 2018, the dog developed difficulty breathing, collapsed and died. A necropsy is pending.
On 31 Oct 2018, preliminary necropsy results revealed a hemopericardium secondary to rupture of a suspected hemangiosarcoma, hyperplasia of the spleen, and chronic degenerative joint disease of the femur and stifle joints.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
N - Unlikely
Reported behavioural change is an unspecific sign and may have numerous other causes, however may be related to product sensation. Breathing difficulty, collapse and subsequent death are not expected. Necropsy revealed hemopericardium secondary to rupture of suspected hemangiosarcoma, which explains the breathing difficulty, collapse and death. Further reported chronic joint disease findings are associated with pre-existing arthritis. Despite close association in time, considering necropsy revealed other cause of clinical signs, a product relation is deemed unlikely.