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Catalog Number 2217 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/03/2023 |
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 provided: during the product was used for tpl (kidney transplant donor).Product placed in retroperitoneal cavity.Additional information has been requested and received.What is the lot number? : unk.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.What was done to address the leak of the drain? was the drain removed and require replacement with a new drain? if yes, was a surgical procedure required to place a new drain? or was the drain removed after fulfilling the drainage function? no product is available for return.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 a urological surgery (b)(6) 2023 and a drain was used.On (b)(6) 2023, in the ward / icu, tear of the drain was observed at the beginning of the groove.Waste fluid was collected with gauze.Further details are not provided.No sample will be returned.There were no adverse consequences to the patient.Additional information has been requested.
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Manufacturer Narrative
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Product complaint # (b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.What was done to address the leak of the drain?=> waste fluid was collected with gauze.Was the drain removed and require replacement with a new drain?=>unk 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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Search Alerts/Recalls
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