Although, requested product identifiers were not provided, therefore a review of the manufacturing records is not possible.
Without having the lot number or sample returned for evaluation, at this time no definitive conclusions can be made regarding the root cause for the reported event.
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.
Patient details are unobtainable due to the privacy laws in (b)(6).
Device remains implanted.
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The following was reported to davol: it was reported that during a bilateral laparoscopic inguinal hernia repair using the tep technique, the surgeon was attempting to secure a bard soft mesh with a bard sorbafix fixation device, however the tack fired through the mesh, creating a hole and didn't hold it in place.
The mesh was left in place and fixated with a non bard/davol fixation device.
There was no patient injury reported.
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