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Catalog Number UPA31015 |
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 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Events submitted via mw# 2210968-2020-10192, and mw# 2210968-2020-10193. attempts are being 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.Attempts are being made to obtain the following information. to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Qjbbpdd0 and qjbcczd0 are not valid lot numbers in the system.Can you confirm the product name and lot numbers involved in the event? 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 that a patient underwent a laparoscopic hernia repair on an unknown date in 2020 and the mesh was used.It was reported that the sterile packaging was perforated.There was no harm to patient.A new device was opened.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: 1/25/2021. a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. an opened foil packet, a paper folder with product were returned for evaluation.During the visual inspection of sample, several wrinkles and holes could be observed on foil packet, the holes appear to be caused from outside to inside and on the wrinkles.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Per the condition of the sample suggest excessive manipulation of foil packet.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.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 # (b)(4).Date sent to the fda: 06/16/2021.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.Product complaint # (b)(4).Date sent to the fda: 06/16/2021.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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