The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "material selection", or "patient specific conditions".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "adverse reactions complications associated with the proper implantation of the avaulta plus¿ biosynthetic support system may include, but are not limited to those typically associated with surgically implantable materials, including: - postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.- urinary retention, bladder outlet obstruction and other voiding and defecatory dysfunctions.These conditions may be associated with over-correction/too much tension placed on the implant.- perforations or lacerations of vessels, nerves, bladder, bowel, urethra, rectum, or any viscera, which may occur during the implantation procedure.- irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.- extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.- inflammation, sensitization, rejection of biologic materials, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of vaginal wall prolapse.- urinary incontinence (stress and urge) baw0302773 revision 0 was reviewed and was found to be adequate according to s03fa211 revision 17.The user guide currently states: adverse reactions complications associated with the proper implantation of the avaulta solo® synthetic support may include, but are not limited to those typically associated with surgically implantable materials, including: - postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.- urinary retention, bladder outlet obstruction and other voiding and defecatory dysfunctions.These conditions may be associated with over-correction/too much tension placed on the implant.- perforations or lacerations of vessels, nerves, bladder, bowel, urethra, rectum, or any viscera, which may occur during the implantation procedure.- irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.- extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.- inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of vaginal wall prolapse.- urinary incontinence (stress and urge)." correction: h11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.
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