Based on the information available at this time, no definitive conclusions can be made.
A review of the manufacturing records was performed and found that the lot was manufactured to specification.
Recurrence and adhesion are both known inherent risks of the surgery and are listed in the adverse reaction section of the ifu as possible complications.
The operative report from the implant procedure was provided confirming the implant of a sepramesh ip device.
A video alleged to be of the revision procedure was provided for review.
There was no visualization of a sepramesh ip in the video, nor did it show any mesh attached to the colon.
A mesh was observed in the video, however it was not a sepramesh ip device.
It is not known if the patient was implanted with other mesh products.
If additional information is obtained, a supplemental 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.
Not returned.
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