Catalog Number PVPM |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
Attempts have been made to retrieve the device.
To date the device has not been returned.
If the device or further details are received at a later date a supplemental medwatch will be sent.
Additional information was requested and the following was obtained: what was the name of the procedure? umbilical hernia repairs.
How was the procedure completed? with another ventral patch.
It was reported that ¿quantity x 2- pug in /removed tabs/ would not stick- photo attached¿, as the photo was not attached to the file, please be specific.
Did the ¿straps¿ not attach to the tissue? the tabs broke off as the mesh was being moved in to position before any fixation of the mesh had begun.
Did the ¿suture loops¿ not attach? was there any issues with the suture? what suture?.
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Event Description
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It was reported that the patient underwent an umbilical hernia repair procedure on (b)(6) 2017 and the mesh was implanted.
During the procedure, the mesh tabs broke off as the mesh was being moved into position before any fixation of the mesh had begun.
Another mesh was used to complete the procedure.
There were no adverse consequences reported.
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Manufacturer Narrative
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The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Provided photo shows a used device with both straps separated and visible partial separation of one wing at the welding with the load ring.
No conclusion could be drawn without physical analysis of the actual sample.
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Search Alerts/Recalls
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