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 "materials of construction are not biocompatible".The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "precautions: pelvisofttm biomesh is for single-patient use only and is to be implanted surgically.If either the outer polyester/polyethylene pouch or the inner foil pouch has been perforated or torn in shipment or storage, then the enclosed pelvisofttm biomesh should not be used.Pelvisofttm biomesh should be hydrated or moist when the package is opened.Dehydrated or dry tissue should not be implanted.Do not use tissue if either inner or outer pouch is punctured, torn or not intact.1.Necessary materials.A.One sterile dish (e.G., kidney dish) per pelvisofttm biomesh.B.Rinse solution; at least 100ml sterile normal saline or sterile lactated ringers solution per pelvisofttm biomesh.C.Sterile non-toothed forceps.2.Preparing and rinsing pelvisofttm biomesh.A.Peel open the outer polyester/polyethylene pouch and aseptically remove the inner foil pouch.The inner foil pouch may be placed in the sterile field.Retain the outer pouch outside of the sterile field until peel-off labels have been placed on the patient records and data card.B.Open the foil (inner) pouch and aseptically remove the pelvisofttm biomesh.C.Pelvisofttm biomesh may be aseptically trimmed to the required dimensions.D.Place each pelvisofttm biomesh in a dish in the sterile field.E.Fill the dish with sufficient amount of solution to rinse each graft.F.Rinse and store graft in the solution until the surgeon is prepared to implant the graft.When handling pelvisofttm biomesh use sterile gloves or sterile, non-toothed forceps to remove the tissue from the dish." h11: section a through f - 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.H3 other text : the device was not returned.
|