Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-2296
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2018-US0025650 (Report 491090)
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.
31-MAY-18
5. Location of incident.
Country: UNITED STATES
Prov / State: PENNSYLVANIA
6. Date incident was first observed.
Unknown
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. Unknown
Product Name: K9advantixII pipette size unknown
- 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.
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 an unknown date in approximately 2017, a 5 year old, neutered, female, Airedale Terrier canine, of unknown weight and condition, with no known concomitant medical conditions, administered monthly an unspecified dose of oral ivermectin since 2017, was administered 1 tube of K9 Advantix II (unspecified) (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?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Airedale Terrier
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
Unknown
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
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Other
- Specify - Abnormal test result
- Symptom - Parasitism
- Specify - lyme disease
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 an unknown date post application, in 2017, the canine was examined by a veterinarian and diagnosed with lyme disease.
Approximately 3 days post diagnosis, in 2017, the canine died. No known necropsy was performed.
Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial phone call was to discuss the use of Seresto on another pet and not to report the death in this event.
No further information is expected. Case is closed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
N - Unlikely
No ticks were reported and thus unclear when the dog contracted the Lyme disease. Moreover Lyme disease has a long incubation period (1-5 months) therefore the animal could have contracted the disease before Advantix application. Death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very low level of information (medical history and time to onset unknown - necropsy not available) as the reason for the initial phone call was to discuss the use of another Bayer product on another pet and not to report the death in this event. Considering all aspects, a product connection is unlikely.