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Model Number 636H |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Attempts have been made to retrieve the device.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.Additional information was requested, and the following was obtained: hair was found inside sterile packaging.Event date: (b)(6), procedure unknown.Event reported via: 2210968-2021-12191.
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Event Description
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It was reported that a patient underwent an unknown procedure in 2021 and suture was used.Before used on the patient, it was reported that in two instances, a piece of hair was found in 2 different packs of suture.There were no 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: 12/29/2021.H6 component code: g07002 no device return.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.
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Search Alerts/Recalls
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