Catalog Number W810T |
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 02/20/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint (b)(4) additional information: h6 component code: g07002 - device not returned additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Are there any photos of the product available? was the sterility of the device compromised? please describe the sterile packaging: were there any issues with the seal of the sterile packaging? are there any tears/holes in the sterile packaging? other information requested is unknown.No product is available for return.Note: events reported on mw (b)(4).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, 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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Event Description
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It was reported a patient underwent an unknown procedure on (b)(6) 2024 and bone wax was used.Product melted.The nurse opened the intact original packaging of bone wax and found that two packages of bone wax were stuck together and had a dissolution phenomenon.They were contaminated and cannot be used.Other bone waxes in the same box are normal and intact.The operating room temperature and humidity meet the storage conditions for bone wax.Additional information has been requested.
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Manufacturer Narrative
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Product complaint #: (b)(4).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 inc 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.Additional information: h6 a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
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Search Alerts/Recalls
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