Currently, it is unknown whether the device may have caused or contributed to the reported event.
It is alleged the patient experienced adhesions and infection.
Adhesions are listed as a known possible adverse reaction in the instructions-for-use.
In regards to infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively.
The prosthesis may not have to be removed.
An unresolved infection, however, may require removal of the prosthesis.
¿ without a lot number a review of the manufacturing records could not be conducted.
With the currently available information, no conclusion can be drawn.
If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.
The information provided by bard represents all of the known information at this time.
Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Device not returned to manufacturer.
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The following was reported to davol by the patient's attorney: on (b)(6) 2015 - the patient underwent implant of a composix e/x mesh to treat a recurrent incisional hernia.
On (b)(6) 2015 - the patient was allegedly diagnosed with "infected mesh" and required a subsequent surgery to remove the composix e/x.
The surgeon excising the mesh alleged that the patient had "multiple adhesions to his abdominal wall," and performed lysis of adhesions allegedly caused by the composix e/x mesh.
The attorney alleges the patient experienced infection, additional surgery, adhesions, permanent injury, defective mesh and explant.
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