New incident report
Incident Report Number: 2012-2030
Registrant Reference Number: 120015377
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
Domestic Animal
Country: UNITED STATES
Prov / State: ALABAMA
PMRA Registration No. PMRA Submission No. EPA Registration No. 2724-485-270
Product Name: Farnam Bio Spot Shampoo For Dogs And Puppies
Liquid
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Medical Professional
Dog / Chien
Toy Fox Terrier
1
Female
10.0
11.0
lbs
Skin
>24 hrs <=3 days / >24 h <=3 jours
>24 hrs <=3 days / >24 h <=3 jours
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On the evening of February 5, 2012 the owner came home and discovered that the dog had died. On February 6, 2012 the owner took the dog's body to the veterinarian and a necropsy was performed. On February 7, 2012 the owner's regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the ingredients in the shampoo product have a wide margin of safety in dogs and that significant signs would not be expected after product use. The owner's regular veterinarian reported that she did not observe anything abnormal on the gross necropsy and that the histopathology had not been sent out. The APSS technician recommended additional necropsy testing.
Death
The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On February 8, 2012 an APSS technician called the regular veterinarian to discuss the necropsy and faxed instructions and the submission form to the clinic. On February 13, 2012 an APSS technician called the diagnostic laboratory to update the case and discuss additional toxicology testing. The diagnostic laboratory stated that the pet's body had been received on February 10, 2012. On February 14, 2012 the interim necropsy results were received. The results revealed presumptive moderate, multifocal endocardiosis in the left atrioventricular valve; presumptive moderate, diffuse hepatic congestion in the liver; and presumptive nephropathy in the left kidney. Due to the initial necropsy performed by the regular veterinarian and the freezing and subsequent thawing of the carcass, the condition of the carcass did not allow for adequate assessment of all tissues, and thus the cause of the dog's death was not apparent upon gross examination. The observed presumptive left atrioventricular valve endocardiosis could be suggestive of a cardiac pathology. Appropriate samples have been taken for histopathology, although the advanced state of autolysis could hinder adequate histological evaluation of the tissue specimens. In addition, samples of the eye, brain, liver, kidney, fat, and skin were taken for toxicology and are currently being held. On February 16, 2012 a second set of interim necropsy results with the histopath report was received. The heart revealed mild multifocal interstitial fibrosis with myofiber hypertrophy and rare degeneration and loss; the endocardium (left atrioventricular valve) revealed moderate chronic diffuse endocardiosis; the liver revealed mild random necrotizing hepatitis; the spleen revealed moderate hemosiderosis; the duodenum revealed minimal multifocal crypt abscess formation; and the kidney revealed mild, diffuse, segmental membranous glomerulonephritis with mild multifocal interstitial fibrosis. Adequate evaluation was hindered because the patient was presented with severe post-mortem autolysis. Although a definitive cause of death was not observed, the observed cardiac and endocardial pathology could be suggestive of a cardiac arrhythmia as a potential cause of death. There was also mild random necrotizing hepatitis, but the extent of the lesion does not suggest clinical significance. The exact etiology of the necrotizing hepatitis could not be established, but bacterial pathogens could be considered. The widespread hepatic and splenic hemosiderosis suggests increased red blood cell destruction or turnover due to an unknown reason. The renal lesions are most likely related to the patient's age. The brain, liver, and skin were sent to another laboratory to rule out toxicity. GCMS toxicant screen of brain, liver, and skin were negative for toxic organic compounds.