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Model Number SPMII |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4). a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. additional information was requested and the following was obtained: please provide procedure name.It is stated: "one foil was used and it seems to be unsterile." please explain how the device was defective.I.E did the foil had any hole or tear? any open or incomplete seal? did the mesh had foreign matter such as dust, moisture, blood, etc? please explain in detail.Was the mesh implanted on the patient or not? if yes, was it removed during the same procedure? were there any patient consequences? if yes, please explain in detail? answers: inguinal hernia surgery.One foil was unfolded, it is opened already.Out of six foils in that box, only one foil did not seal properly.They didn't use that mesh.There are no patient consequences.
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Event Description
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It was reported that a patient underwent an inguinal hernia repair procedure on an unknown date and the mesh was used.It was reported that prior to the procedure, the foil packaging of the device was unfolded and opened.The foil packaging was not sealed properly so the device appeared to be unsterile.The mesh 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: 11/27/2021.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.H3 evaluation: a piece of the box and one mesh product code was returned for analysis.The foil packet was not received for evaluation.In order to evaluate the conditions of the returned sample, the mesh was observed intact, no damages could be observed.In addition, the mesh was observed to be placed on a plastic paper with irregular cuts in the edges that means that this paper was not part of packaging process.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
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Search Alerts/Recalls
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