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Model Number PCDG1 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (b)(4).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 a patient underwent a hernia procedure on (b)(6) 2020 and the mesh was used.It was reported that human hair is contained in the mesh product.A like device was used to complete the procedure.There were no adverse patient consequences reported.
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Manufacturer Narrative
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Product complaint # (b)(4).Date sent to the fda: 10/01/2020.Additional information: d10.H3 evaluation: the analysis results found the sample was received open and foreign matter was noted to be inside the package.The foreign matter was submitted for fractographic and ftir evaluation to determine the material composition.A microscope was used to examine the foreign matter.During the evaluation it was noted that the scale and surface of the foreign matter is indicative of a hair.In addition, an ftir evaluation was performed and the composition of the foreign matter was identified as biologic material and consistent with a human hair.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.A review of the complaint data base was done, and no additional complaints have been reported related with the same lot.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.
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Manufacturer Narrative
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Product complaint # pc-(b)(4).Date sent to the fda: 09/10/2020.Additional information: d4, h4, h6 - method codes.H3 evaluation: one picture was provided for analysis.Upon visual inspection of the picture, a foreign matter in the center of the mesh product could be observed.However, no conclusion could be reach as the sample was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Additional information was requested and the following was obtained: how the procedure was complete? -replace new one.Please provide procedure name and date: -procedure is ¿hernia¿, date is unknown.Current patient status? -no information.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.
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Search Alerts/Recalls
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