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Catalog Number PMSK1 |
Device Problems
Delivered as Unsterile Product (1421); Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Additional information was requested and the following was obtained: please provide procedure name: no response.Please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail : no.How was procedure successfully completed? another device was used.The name of the procedure : digestive surgery and cancer / right inguinal hernia to be specified.Attempts are being made to obtain the following information. to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is meant by ¿primary package¿? do you mean the sales carton or the tyvek overwrap (foil/ pouch)? what is meant by ¿secondary package¿? do you mean the tyvek overwrap (foil/ pouch) or the paper folder? can you provide a photo?.
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Event Description
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It was reported that a patient underwent a digestive surgery on (b)(6) 2021 and the mesh was used.It was reported that upon opening the secondary packaging by the nurse, the primary packaging to contain the protheses was properly closed but when the instrumentalist opened it, he noticed that the prothesis was missing inside.The prothesis was slipped in the secondary packaging, so it was impossible to use as it was not sterile.The device was not used.There were no adverse patient consequences reported.Additional information was requested.
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Manufacturer Narrative
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Product complaint #(b)(4) date sent to the fda: 10/01/2021 this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts have been made to retrieve the device.To date only the package was received however, 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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Search Alerts/Recalls
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