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Catalog Number PDP358T |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2023 |
Event Type
malfunction
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Event Description
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It was reported that the patient underwent an unknown surgery on 12-december-2023 and suture was used.During the surgery, when the doctor used the suture to pull the patient's muscles, the suture broke and was discarded and not used.No patient consequence was reported.Additional information was requested.
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Manufacturer Narrative
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(b)(4).This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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.The following information was requested, but unavailable: ¿ did this issue contribute to any patient adverse event? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.
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Manufacturer Narrative
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Product complaint # (b)(4).Date sent to the fda: 4/23/2024.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.
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Search Alerts/Recalls
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