New incident report
Incident Report Number: 2016-7940
Registrant Reference Number: 2016KP221
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-128
Product Name: k9 advantix II small dog
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Pomeranian
1
Female
9
4.9
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>30 min <=2 hrs / >30 min <=2 h
System
Persisted until death
Yes
Yes
1
Day(s) / Jour(s)
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately one hour following the application of product, the dog became pruritic, agitated, and began panting. The owner bathed the dog with liquid dish soap. The dog presented to the emergency clinic. The dog was hospitalized due to difficulty breathing. The dog was administered torbugesic with acepromazine intravenously (unknown dose), dexamethasone (unknown dose) intravenously, and diphenhydramine (unknown dose) intravenously. The dog was placed in an oxygen cage. On 10Sep2016 the dog was released into the owners' care. On 11Sep2016, the dog presented to the emergency clinic with difficulty breathing. The dog was started on intravenous fluids and placed in an oxygen cage. Chest radiographs, complete blood count, and blood gases were performed. The dog was administered acepromazine (unknown dose), diazepam (unknown dose), prednisone, and diphenhydramine. The dog continued to worsen. The dog was administered butorphanol with intermittent midazolam and acepromazine (unknown doses), and manual ventilation was started. Bloodwork revealed coagulopathy. On 12Sep2016, the dog went into cardiac arrest and died. No necropsy was performed. No further information is expected. This case is closed. Follow up received on 4th Oct 2016: On 09-Sep-2016, a 9 year old, 4.9 pound, neutered, female, Pomeranian canine, in poor condition, with a concomitant collapsing trachea, who was administered unknown oral doses of butorphanol tartrate and diphenhydramine daily since 2016 for the concomitant medical condition, was administered 1 tube of K9 Advantix II Small Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. Approximately 3 hours post application, the dog was examined by the emergency veterinarian, administered unspecified doses of intravenous torbugesic, intravenous acepromazine maleate, intravenous dexamethasone, and intravenous diphenhydramine. The dog was hospitalized in an oxygen cage and the collar was removed. On 10 Sep2016, the clinical signs continued but improved and dog was discharged to the owner. On 11Sep2016, the dog exhibited difficulty breathing and was examined by the emergency veterinarian. Thoracic radiographs, complete blood count, and blood gases were performed; the results are unknown. The dog was administered unspecified doses of acepromazine maleate, diazepam, prednisone, and diphenhydramine. The clinical signs worsened. The dog was administered unspecified doses of butorphanol tartrate via constant rate infusion with intermittent dose of intravenous midazolam and acepromazine maleate. An endotracheal tube was placed and manual ventilation was performed. Bloodwork revealed disseminated intravascular coagulation.
Death
Though would not expect generalized skin disorders after topical application, reported pruritus and agitation may reflect paresthesia caused by permethrin. Panting is not expected however rather consequence of agitation. Time to onset consistent. Further reported difficulty in breathing is not expected either. Other causes should be considered, e.g. concomitant medical condition of collapsing trachea. Reported disseminated intravascular coagulation and cardiac arrest are not anticipated after product application as they are inconsistent with pharmaco-toxicological product profile. The dog likely died due to serious underlying condition. Even though time to onset is short for initially reported signs, considering long time to onset for further reported unexpected signs, a product relation is deemed to be unassessable.