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Catalog Number 5954460 |
Device Problem
Expiration Date Error (2528)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The user facility reported that they inadvertently implanted an expired ventralight st mesh into the patient.The expiration date is located on multiple layers of the packaging.This event is confirmed as a use related error with no malfunction of the device.As reported, there was no reported patient injury, and no additional surgical intervention was required.No lot number has been provided, therefore, a review of the manufacturing records is not possible. should additional information be provided, a supplemental mdr will be submitted.Device not returned; remained implanted.
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Event Description
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As reported, on (b)(6) 2020, during an unknown procedure, the physician implanted a ventra-light st 4" x 6" mesh which had expired on 28-oct-2020.As reported, the mesh was not explanted and no other additional surgical intervention was performed.There was no reported patient injury.
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Search Alerts/Recalls
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