Catalog Number PHSL |
Device Problem
Migration (4003)
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Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Perforation (2001); Hernia (2240); Foreign Body In Patient (2687); Not Applicable (3189)
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Event Date 04/04/2018 |
Event Type
Injury
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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.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.If in your possession, may we have a copy of your operative report of the initial hernial repair in 2005 and any subsequent surgeries for hernia repair? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation?.
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Event Description
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It was reported that a patient underwent a hernia repair procedure on (b)(6) 2005 and the mesh was implanted.It was reported that the patient had abdominal symptoms that were caused by hernia mesh migration and adhesion.It was also reported that the patient was diagnosed with both aerobic and anaerobic infection.It was reported that the patient had surgeries to drain, and eventually repair hernia and resection colon.
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Manufacturer Narrative
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Date sent to the fda: 01/10/2020.Corrected h-6 patient codes: 2240, 1695, 1930, 3189- surgical intervention.Additional b5 narrative: the explant date was reported as (b)(6) 2018.Additional note: this medwatch report is in response to receipt of maude event report mw5091073.
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Manufacturer Narrative
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Product complaint(b)(4).Date sent to the fda: 01/27/2020.Additional b5 narrative: it was reported that a patient underwent a hernia repair procedure on (b)(6) 2005 and the mesh was implanted.It was reported that the patient had abdominal symptoms that were caused by hernia mesh migration and adhesion.It was also reported that the patient was diagnosed with both aerobic and anaerobic infection.It was reported that the patient had surgeries to drain, and eventually repair hernia and resection colon.It was also reported that the hernia repair mesh migrated and perforated the patient's intestine.It was reported that this and the resulting surgeries to repair the damage caused imminent and long-term pain, reduced activities, and exposure to infection.
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Manufacturer Narrative
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(b)(4).Additional b6 narrative: it was reported that a patient underwent a hernia repair procedure on (b)(6) 2005 and the mesh was implanted.It was reported that the patient had abdominal symptoms that were caused by hernia mesh migration and adhesion.It was also reported that the patient was diagnosed with both aerobic and anaerobic infection.It was reported that the patient had surgeries to drain, and eventually repair hernia and resection colon.It was also reported that the hernia repair mesh migrated and perforated the patient's intestine.It was reported that this and the resulting surgeries to repair the damage caused imminent and long-term pain, reduced activities, and exposure to infection.
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Manufacturer Narrative
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Date sent to the fda: 2/26/2020.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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