|
Model Number TEM1208GR |
Device Problem
Material Split, Cut or Torn (4008)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 09/14/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter: during repair of inguinal hernia, the mesh tore when pulling the flap part of a device lightly.The procedure was completed with another device.No injury.
|
|
Manufacturer Narrative
|
Evaluation summary: one device was returned.As no lot number was provided, a review of the device history record could not be performed.All process and test criteria are verified as complying with qa specifications for all product lots prior release to market.The visual examination of the returned sample shows that: the sample was returned in its original commercial box.The textile knitting pattern and the mesh dimensions were found as expected.The flap was found detached from the mesh.Due to the sewing visible yarns the flap seems to have been torn.Conclusion of the visual examination: the reported condition was confirmed.Based on the available information, our investigation and a complaint history review, the manufacture of the device is not suspected.There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend.The reported incident is confirmed but the root cause could not be determined.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|