MAUDE Adverse Event Report: GENZYME CORPORATION(FRAMINGHAM) SEPRAFILM; MCN

GENZYME CORPORATION(FRAMINGHAM) SEPRAFILM; MCN

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Model Number 5959480

Device Problem Defective Device (2588)

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

Event Date 02/27/2009

Event Type Injury

Manufacturer Narrative

Sanofi company comment dated 15-aug-2018: this case concerns a female patient who received treatment with seprafilm and later underwent surgeries due to mesh-related complications and also had permanent disability and serious injury due to physical pain.The relationship of the event with suspect cannot be denied.However, further information regarding patient¿s current clinical presentation, onset latencies and other risk factors precludes the complete medical case assessment.

Event Description

Mesh-related complications [complication associated with device] ([device defective]) physical pain [pain].Case narrative: upon internal review on 26-nov-2018, suspect product was updated from seprafilm to sepramesh ip and the case was downgraded from valid to non-valid (since the suspect product sepramesh is no longer manufactured by sanofi and is the responsibility of the new marketing authorization holder).Initial information received on 15-aug-2018 regarding an unsolicited non valid serious case received from a lawyer from united states.This case involves an adult female patient who experienced mesh-related complications and physical pain, while she was using with the use of medical device carboxymethyl cellulose, polyglycolic acid, polypropylene, sodium hyaluronate (sepramesh ip).The reported lot number of the device was noted to be defective.The patients past medical history included incisional hernia.The patient past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2009, the patient started using sepramesh ip (lot - 08np148) for incisional hernia repair.On (b)(6) 2009, the patient underwent an additional surgery to remove the sepramesh ip, after it had failed to repair the recurrent hernia.It was alleged that the patient endured additional surgeries to treat mesh-related complications.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 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.A product technical complaint was initiated on 21-aug-2018 for sepramesh ip.Batch number: 08np148, global ptc number: 55169.Bard complaint no.1070558, sepramesh lot 08np148, part number 5959480.Date of sealing: 23-may-08, date of sterilization: 18-may-08, date of expiration: 31-may-10.There was one deviation associated with the manufacture of this lot, b01-sepra-dev-204.This deviation was initiated due to the outdoor damper for ahu #1 at 74 nya being closed and no alarm sounding.This was a facilities related deviation and is only associated with this lot of sepramesh because it was in process at the time in one of the 74nya manufacturing suites.A capa was assigned to facilities to get the damper on line with the bms alarm system.It was determined that there was no product impact to the sepramesh and the lot was released upon deviation closure.There were no other anomalies 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.Sepramesh was sealed into a plastic tray with tyvek cover which is then sealed into a foil pouch.At the time of lot 08np148's manufacture, all foil pouches were 100% inspected.Foil pouch seal widths were aql inspected by genzyme quality assurance.Lastly, a reference to bard's raw material specification was added to the certificate of analysis at customer request.All three of these changes were later permanently incorporated into the sepramesh manufacturing and qa processes.There are two additional complaints for lot 08np148.One dated 17 aug 2018, refer to related file from bard (b)(4) (two of the same device with the same product identifiers were implanted in the patient).The other dated 05 may 2009, for one 3x6 piece of sepramesh which displayed a slit through the foil pouch on the non-labeled side at the bottom of the seal on the chevron end.The product was returned.Conclusion: there were no failed inspections and no anomalies noted in the production batch record or qc data review for lot 08np148.Review of coa for 08np148 confirmed that all release test results met required specifications.Review of lot 08np148 sterilization certificate confirmed that lot sterility specifications were met.Seriousness criteria: required intervention and disability for both events.Additional information was received on 01-oct-2018.Global ptc number and results were added.Upon internal review on 26-nov-2018, the following changes were made (since this batch was identified in context of incorrect suspect product): suspect product was updated from seprafilm to sepramesh ip and the case was downgraded from valid to non-valid (since the suspect product sepramesh is no longer manufactured by sanofi and is the responsibility of the new marketing authorization holder).

Manufacturer Narrative

Sanofi company comment for follow-up dated 01-oct-2018: new follow-up information received does not change the previous assessment of this case.This case concerns a female patient who received treatment with sepramesh ip and later underwent surgeries due to mesh-related complications and also had permanent disability and serious injury due to physical pain.The relationship of the event with suspect cannot be denied.However, further information regarding patient¿s current clinical presentation, onset latencies and other risk factors precludes the complete medical case assessment.

Event Description

Mesh-related complications [complication associated with device] ([device defective]) physical pain [pain].Case narrative: initial information received on 15-aug-2018 regarding an unsolicited valid serious case received from a lawyer from united states.This case involves an adult female patient who experienced mesh-related complications and physical pain, while she was using with the use of medical device carboxymethyl cellulose, polypropylene, sodium hyaluronate (sepramesh).The reported lot number of the device was noted to be defective.The patients past medical history included incisional hernia.The patient past medical treatment(s), vaccination(s) and family history were not provided.On(b)(6) 2009, the patient started using sepramesh (lot - 08np148) for incisional hernia repair.On (b)(6) 2009, the patient underwent an additional surgery to remove the sepramesh, after it had failed to repair the recurrent hernia.It was alleged that the patient endured additional surgeries to treat mesh-related complications.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 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.A product technical complaint was initiated on (b)(6) 2018 for sepramesh.Batch number: 08np148, global ptc number: (b)(4).Bard complaint no.1070558, sepramesh lot 08np148, part number 5959480.Date of sealing: (b)(6) 2008, date of sterilization:(b)(6) 2008, date of expiration: 31-may-10.There was one deviation associated with the manufacture of this lot, b01-sepra-dev-204.This deviation was initiated due to the outdoor damper for ahu #1 at 74 nya being closed and no alarm sounding.This was a facilities related deviation and is only associated with this lot of sepramesh because it was in process at the time in one of the 74nya manufacturing suites.A capa was assigned to facilities to get the damper on line with the bms alarm system.It was determined that there was no product impact to the sepramesh and the lot was released upon deviation closure.There were no other anomalies 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.Sepramesh was sealed into a plastic tray with tyvek cover which is then sealed into a foil pouch.At the time of lot 08np148's manufacture, all foil pouches were 100% inspected.Foil pouch seal widths were aql inspected by genzyme quality assurance.Lastly, a reference to bard's raw material specification was added to the certificate of analysis at customer request.All three of these changes were later permanently incorporated into the sepramesh manufacturing and qa processes.There are two additional complaints for lot 08np148.One dated (b)(6) 2018, refer to related file from bard (b)(4) (two of the same device with the same product identifiers were implanted in the patient).The other dated (b)(6) 2009, for one 3x6 piece of sepramesh which displayed a slit through the foil pouch on the non-labeled side at the bottom of the seal on the chevron end.The product was returned.Conclusion: there were no failed inspections and no anomalies noted in the production batch record or qc data review for lot 08np148.Review of coa for 08np148 confirmed that all release test results met required specifications.Review of lot 08np148 sterilization certificate confirmed that lot sterility specifications were met.Seriousness criteria: required intervention and disability for both events additional information was received on 01-oct-2018.Global ptc number and results were added.

Manufacturer Narrative

Sanofi company comment for follow-up dated (b)(6) 2018: new follow-up information received does not change the previous assessment of this case.This case concerns a female patient who received treatment with sepramesh and later underwent surgeries due to mesh-related complications and also had permanent disability and serious injury due to physical pain.The relationship of the event with suspect cannot be denied.However, further information regarding patient¿s current clinical presentation, onset latencies and other risk factors precludes the complete medical case assessment.

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Brand Name

SEPRAFILM

Type of Device

MCN

Manufacturer (Section D)

GENZYME CORPORATION(FRAMINGHAM)

76 new york avenue

framingham MA 01701

MDR Report Key

7923056

MDR Text Key

122302600

Report Number

1220423-2018-00616

Device Sequence Number

Product Code

MCN

UDI-Device Identifier

00801741031816

UDI-Public

(01)00801741031816(10)WBSLS232

Combination Product (y/n)

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Type of Report

Initial,Followup,Followup

Report Date

02/13/2019

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?

Device Operator

Health Professional

Device Model Number

5959480

Device Catalogue Number

5959480

Device Lot Number

08NP148

Was Device Available for Evaluation?

Yes

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

10/01/2018

Supplement Dates Manufacturer Received

Not provided
Not provided

Supplement Dates FDA Received

10/25/2018
02/13/2019

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Required Intervention; Disability;

MAUDE Adverse Event Report: GENZYME CORPORATION(FRAMINGHAM) SEPRAFILM; MCN

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