Catalog Number PML |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
Attempts are being 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.
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Event Description
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It was reported that the patient underwent an unknown procedure on an unknown date and mesh was used.
After opening the box, the secondary packaging was found open.
There were no adverse patient consequences reported.
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Manufacturer Narrative
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(b)(4).
Date sent to the fda: 02/14/2019.
Additional: pml lot v8002 received in opened condition.
Actual sample consisted of 1 opened folder with mesh and sbf.
Tamper proof stickers were checked and found peeled-off at the time of opening.
Retained samples of the incident code and lot was retrieved for visual inspection.
The primary folder of retain samples were visually inspected for presence of desired pack components and found satisfactory.
All the retain samples were visually checked for package integrity and observed sealed from all sides.
Seal strength reports at the time of release were checked and results were within the specification limits.
This is one and isolated case.
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Search Alerts/Recalls
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