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Model 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 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4). a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. device evaluation: device has been returned and evaluation anticipated, but not yet begun. event related to device with reported lot qmbdkbd0 submitted via mw # 2210968-2021-02749 event related to device with reported lot qpbscdd0 submitted via mw # 2210968-2021-02751.
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Event Description
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It was reported that a patient underwent a hernia repair on an unknown date in (b)(6) 2021 and the mesh was used.Prior to surgery there were holes found in foil of device.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: 4/22/2021. h3 evaluation: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that one empty opened foil of product was received 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.The mesh product was not received for evaluation.Per the condition of the sample received, an excessive manipulation of foil packet is suspected.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.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.Product complaint # (b)(4).Date sent to the fda: 4/22/2021.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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Manufacturer Narrative
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Product complaint # (b)(4).Date sent to the fda: 5/25/2021.Additional information provided: storage: the mesh is always placed in the secondary packaging box.No rubber bands or similar are used.Way to the operating room: always placed in secondary packing and never removed; yes, the take several meshes but all in individual original packing; the storeroom is adjacent to the or so they take it directly to the operating table; thus, the meshes are always carried by the nurse, so in case the mesh is not used, she places it back in the storeroom.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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