According to instruction for use (art-20524b 09/2016) under potential complications, it states: allergic reaction to ecm, hematoma and seroma.
Under the section labeled "contraindications: the cormatrix cangaroo ecm envelope is derived from a porcine source and should not be used in patients with a known sensitivity to porcine material.
" under the section warnings and precautions, it states in part, "do not use the cormatrix cangaroo with fibrin glue or glue containing glutaraldehyde or other cross-linking agents.
" under the section suggested instructions for implanting the cormatrix cangaroo ecm envelope it states in part, "hydrate the cormatrix cangaroo ecm envelope by completely immersing it in a bowl of sterile water, sterile saline or sterile lactated ringers solution for 1-2 minutes prior to use.
" the ifu for cangaroo states in part, ""do not use the cormatrix cangaroo with fibrin glue or glue containing glutaraldehyde or other cross-linking agents.
" it can be noted that the pocket was flushed with an "antibiotic solution", however the medical records do not indicate what antibiotic solution was used.
According to the medical records the patient is allergic to amoxicillin.
Although the exact cause of the reported event cannot be conclusively determined, seroma, hematoma and allergic reaction are known potential complications with the cangaroo ecm.
It can also be noted that the cangaroo ecm should not be used with any other cross-linking agents.
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It was reported that on (b)(6) 2018, a (b)(6) year-old male patient ((b)(6), white/not hispanic or latino) had an implant of a cangaroo product (size medium, lot unknown).
Approximately 10 days later the patient developed a seroma which was stated by implanting physician to be a "normal reaction to surgery" and to wait for swelling to go down (event observed in united states).
Approximately 7 weeks later, the wound had not healed and burst.
Cultures were taken and it was reported that "normal body flora was present, no bacteria" (observed in (b)(6)).
The patient went to a different doctor on (b)(6) 2018 for consult (completed in (b)(6)).
On (b)(6) 2018 the ecm device was removed and a hematoma behind the pocket as well as a foreign body reaction was observed (observed in (b)(6)).
Additional information has been requested.
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