|
Catalog Number 0115610 |
Device Problem
Material Split, Cut or Torn (4008)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/15/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
As reported, upon opening the package of modified onflex mesh, damage was noted on the sealed edge.The subject device has been returned for evaluation.Initial evaluation of the sample found that the heat-sealed edge is partially torn off the mesh.The sample evaluation is on-going at this time, as such root cause determination has not been determined.When sample evaluation is completed, a supplemental emdr will be submitted.Review of manufacturing records shows the product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in april, 2021.
|
|
Event Description
|
As reported, upon opening the package of the bard/davol modified onflex mesh on (b)(6) 2021, it was noted that the sealed edge was peeled off all around.As reported, no damage was noted to the outer or inner packaging.It was reported that the mesh was not used on the patient.There was no reported patient injury.
|
|
Manufacturer Narrative
|
As reported, upon opening the package of modified onflex mesh, damage was noted on the sealed edge.The subject device has been returned for evaluation.Initial evaluation of the sample found that the heat-sealed edge is partially torn off the mesh.The sample evaluation is on-going at this time, as such root cause determination has not been determined.When sample evaluation is completed, a supplemental emdr will be submitted.Review of manufacturing records shows the product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of(b)(4) units released for distribution in april, 2021.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of sample evaluation.Evaluation of the returned sample noted the edge seal to be partially torn-off the mesh.The event was reported as an out-of-box condition.Per the investigation performed and sample evaluation, the most probable root cause appears to be related to manufacturing.Note: section a through f - the information provided by bd 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 bd.H3 other text : sample evaluated.
|
|
Event Description
|
As reported, upon opening the package of the bard/davol modified onflex mesh on 15-nov-2021, it was noted that the sealed edge was peeled off all around.As reported, no damage was noted to the outer or inner packaging.It was reported that the mesh was not used on the patient.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|
|