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Bladder wall laceration and lysis of adhesions [procedural complication] ([device defective]).Physical pain [pain].Case narrative: initial information received from united states on 15-aug-2018 regarding an unsolicited valid serious case received from a lawyer from united states.This case involves adult female patient who had bladder wall laceration and lysis of adhesions, physical pain while she was using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The reported lot number of the device was noted to be defective.The patients past medical history included incisional type hernia.The patient past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2009, the patient started using seprafilm (lot - 08np149) for incisional type hernia.It is alleged that several years later on (b)(6) 2011, the patient underwent an additional surgery to remove the abdominal wall mesh, repair of bladder wall laceration, and lysis of adhesions.The patient was injured severely and permanently and had suffered and would continue to suffer physical pain due to the defective device.Final diagnosis was physical pain and underwent an additional surgery to remove the abdominal wall mesh, repair of bladder wall laceration, and lysis of adhesions.Corrective treatment: abdominal mesh removed by surgery for bladder wall laceration and lysis of adhesions; not reported for physical pain outcome: not recovered for physical pain; unknown bladder wall laceration and lysis of adhesions seriousness criteria: required intervention and disability for all events a product technical complaint (ptc) was initiated on 31-aug-2018 for "sepramesh ip", lot number "08np149", date of sealing (post eto): (b)(6) 2008, date of sterilization: (b)(6) 2008, date of expiration: 31may2010, global ptc number: (b)(4).No deviations were associated with the manufacture of this lot.The lot passed all in-process and final product quality assurance inspections with all manufacturing parameters being met and all qc testing attributes being within specification.At the time of lot 08np149 manufacture, all foil pouches were being 100% inspected prior to use by genzyme manufacturing per temporary change (b)(4) and were being 100% inspected post conditioning operation per (b)(4).Additional instruction was added for tray placement into the foil pouch per (b)(4) and foil pouch seal widths were aql inspected by genzyme quality assurance following manufacturing operations (in addition to normal qa aql inspections) per (b)(4).All four of these changes were later permanently incorporated into the sepramesh manufacturing and qa processes.There was one additional complaint for lot 08np149.(b)(4) was due to a small pin hole approximately 0.025 in diameter that penetrated entirely through the foil pouch.This was noted for part# 5959-812 which was a different size and part number pouch.The hole was located on the back, non-labeled, portion of the pouch in the upper section and lined up with the bottom edge of the thermo-formed plastic tray inside.There was a scratch on the outside of the pouch which lead up to the pin hole and indicated that the pouch could have been dragged or slid over an area which was rough or had a burr.The scratch was narrow and would indicate a burr more than an entire rough surface.The pouch was opened and inspected from the inside.There was no rough area noted on the portion of the thermos formed tray which came in contact with the affected portion of the pouch.This would indicate that the pouch had come in contact with a rough surface from the outside.(b)(4) investigation details confirmed that the event was classified as package damage.Thorough investigation of genzyme manufacturing process was completed.No exact root cause could be established as to at what point in the sepramesh process the hole occurred.Capa (b)(4) was initiated to address the issue of the pin holes/ small tears possibly occurring during the genzyme process.There were no failed inspections and no anomalies noted in the production batch record or qc data review for lot 08np149.Review of coa for 08np149 confirmed that all release test results met required specifications.Review of lot 08np149 sterilization certificate confirmed that lot sterility specifications were met.Final investigation complete date was 31-aug-2018.Additional information was received on 31-aug-2018 in the form of investigation summary.Ptc number and results were added.Follow up information received on 19-oct-2018.No new information was received.
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