MAUDE Adverse Event Report: GENZYME BIOSURGERY (SEPRAMESH) SEPRAMESH IP; MCN

Lot Number 06NP204

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 12/01/2015

Event Type  Injury  

Event Description

Injured severely and permanently [injury nos].Physical pain [pain].Mental anguish [anguish].Case narrative: upon internal review on 06-feb-2019 with clock start date of 14-dec-2018, the case was updated as valid.Also, this case was found to be duplicate of case (b)(4), hence all the information was merged into case (b)(4) and case (b)(4) was prepared for deletion.Initial information received on 06-dec-2018 from united states regarding an unsolicited valid legal serious case received from a lawyer.This case involves a female patient who experienced injured severely and permanently, physical pain and mental anguish, with the use of medical device carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate [sepramesh ip].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On or about (b)(6) 2007, the patient was implanted sepramesh ip (carboxymethylcellulose, polyglycolic acid, polypropylene, sodium hyaluronate) (lot - 06np204; expiration: aug-2007) for repair of hernia defect.On or about (b)(6) 2015, the patient underwent surgery to remove the sepramesh ip, which failed.The patient was injured severely and permanently (latency: 8 years).It was reported that during the surgery, a segment of her small bowel was resected so as to remove the mesh in entirety.Further, it was reported that the patient suffered physical pain (latency: 8 years) and mental anguish (latency: 8 years) and would continue to suffer from the same.Corrective treatment: not reported.Outcome: not recovered/not resolved for all events.Seriousness criterion: disability for injured severely and permanently.A product technical complaint (ptc) was initiated on 12-dec-2018 for sepramesh ip.Batch number: 06np204; global ptc number: (b)(4).Lot record review performed 14dec18 for (b)(4).Sepramesh lot 06np204 date of sterilization 15aug06, expiration date 2007-08.There was one deviation associated with the manufacture of lot, related to missing a product insert from the production batch record and had no impact to product quality.All foil pouches were being 100% inspected, in response to a raw material (pouch) defect and for further trending data before use and qa was performing a 100% inspection post conditioning operation per approved temporary change requests (tcrs) (b)(4).These inspections were performed in addition to normal qa aql inspections, which all passed (0 defects).No other non-routine events or anomalies associated with this lot manufacturing, passed all in-process and final product quality assurance inspections and all qc testing attributes being within specification.Product event lot trending: there were two additional events ((b)(4)) associated with lot 06np204: both ae reported to gemg on the same date, 05nov18, from same reporter.(b)(4): female patient, ae: adhesions (2011); infection, fistula, bowel perf, long healing wounds, mesh removal (2015); 2015 record references 8 hernia repairs after the first repair in 2011.(b)(4) ae regarding female patient, ae: infected mesh (b)(6) 2003.Investigation conclusion: there were no failed inspections and no anomalies noted in the production batch record or qc test data for lot 06np204 which would be causal to this adverse event.Review of coa for 06np204 confirmed that all release test results met required specifications.Review of lot 06np204 sterilization certificate confirmed that sterility requirements were met.No capa required.No manufacturing root cause determined through this investigation review.Sepramesh no longer manufactured by (sanofi-) genzyme.Follow up received on 09-jan-2019.No new information was received.Additional information was received on 01-feb-2019.Global ptc results were added.Text amended accordingly.

• Brand Name: SEPRAMESH IP
• Type of Device: MCN
• Manufacturer (Section D): GENZYME BIOSURGERY (SEPRAMESH); 76 new york avenue; framingham 01701
• Manufacturer (Section G): GENZYME BIOSURGERY (SEPRAMESH); 76 new york avenue; framingham 01701
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 8344689
• MDR Text Key: 136315954
• Report Number: 1221601-2019-00002
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2007
• Device Lot Number: 06NP204
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability