MAUDE Adverse Event Report: GENZYME BIOSURGERY (SEPRAFILM/PACK) SEPRAFILM; MCN

Model Number 5959812

Device Problem Defective Device (2588)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Event Description

Mesh-related complications [complication associated with device].Physical pain [pain].Defective sepramesh ip [device defective].Case narrative: initial information received on (b)(6) 2018 regarding an unsolicited valid serious case received from a lawyer from united states.This case involves adult female patient who received medical device carboxymethylcellulose, sodium hyaluronate (seprafilm) and after unknown latency experienced mesh-related complications and physical pain.The reported lot number of the device was noted to be defective.The patients past medical history included ventral hernia.The patient past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2008, the patient received seprafilm (lot - 07np371 exp date 30-nov-2009) for ventral hernia repair.On (b)(6) 2009, after 1 year, the patient underwent an additional surgery to remove the sepramesh ip, which failed and was infected.As reported, the patient endured additional surgeries to treat mesh-related complications (onset date: unknown).As alleged, the patient was injured severely and permanently and had suffered and would continue to suffer physical pain due to the alleged defective sepramesh ip (onset date: unknown).Final diagnosis was physical pain and mesh-related complications.Corrective treatment: surgery for mesh-related complications; not reported for physical pain.Outcome: not recovered for physical pain; unknown for mesh-related complications.Seriousness criteria: required intervention and disability for both events.A product technical complaint was initiated with global ptc number: (b)(4).A product technical complaint (ptc) was initiated on (b)(4) 2018 for "sepramesh ip".Batch number 07np371, global ptc number: (b)(4).Sepramesh lot 07np371 date of sterilization was (b)(6) 2007, expiration date: 30-nov-2009.There was one deviation associated with the manufacture of this lot due to a temperature excursion in a water bath.Per qa management assessment, the low-end temperature was determined to not have an effect on product.Trending of pristine sheets peeled, and acceptable full sheets were well within the required limits.The lot passed all in-process and final product quality assurance inspections with all manufacturing parameters being met and all qc testing attributes within required release specifications.Sepramesh was sealed into a plastic tray with tyvek cover which was then sealed into a foil pouch.At the time of lot 07np371 manufacture, per temporary change request (tcr) (b)(4), manufacturing was performing 100% inspection of foil pouches before use.Per temporary change (b)(4), qa was to perform 100% inspection of pouches following post-conditioning operation.Additionally, per (b)(4), all lots currently in inventory were 100% inspected for seal width to ensure they were inch.Lastly, per (b)(4) a reference to bard raw material specification was being added to certificate of analysis.There are no other complaints or adverse events associated with lot 07np371.There were no failed inspections and no anomalies noted in the production batch record or qc data review for lot 07np371.As there were no anomalies or issues found with the lot during batch review, no corrective action was required.Additional information was received on 24-aug-2018.Global ptc number & ptc results were added.Expiration date was added.Text was amended accordingly.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME BIOSURGERY (SEPRAFILM/PACK); 76 new york avenue; framingham MA 01701
• Manufacturer (Section G): GENZYME BIOSURGERY (SEPRAFILM/PACK); 76 new york avenue; framingham MA 01701
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 7927754
• MDR Text Key: 122458167
• Report Number: 2246315-2018-00637
• Device Sequence Number: 1
• Product Code: MCN
• UDI-Device Identifier: 00801741031830
• UDI-Public: (01)00801741031830(10)WBSAS039
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/02/2018

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: 11/30/2009
• Device Model Number: 5959812
• Device Catalogue Number: 5959812
• Device Lot Number: 07NP371
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability