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

Lot Number 8BYSEP017

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

Patient Problems Edema (1820); Unspecified Infection (1930); Rash (2033); No Code Available (3191)

Event Date 03/17/2019

Event Type  Injury  

Event Description

Hemodynamic failure (circulatory collapse) [circulatory collapse], inflammatory red patches on the skin [skin inflammation] ([skin edema], [erythematous skin rash]), wound secretion [wound secretion].Case narrative: the case was cross referenced with cases: (b)(4) (multiple devices for same patient).Initial information received from (b)(6) on 19-mar-2019 and 25-mar-2019 processed together with clock start date of 19-mar-2019 regarding an unsolicited valid serious case received from a pharmacist and health authority (reference number: (b)(4)).This case involves (b)(6) male patient who used medical device carboxymethylcellulose, sodium hyaluronate (seprafilm) and experienced hemodynamic failure (circulatory collapse) (latency: 11 days), inflammatory red patches on the skin (latency: 8 days), wound secretion (latency: 11 days).The patient's past medical history included previous 3 laparotomy and patient had same reactions and each time a germ was found and postoperative infection was suspected.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2019, the patient underwent laparotomy which was the fourth one and was inserted with carboxymethylcellulose, sodium hyaluronate (lot - 8bysep017) for adherence prophylaxis after surgery.On (b)(6) 2019, the patient experienced an erythematous skin rash with inflammatory red patches on the skin, and edemas (latency: 8 days).On (b)(6) 2019 (two or three days later), the patient presented wound secretion and hemodynamic failure (circulatory collapse) (latency: 11 days).Also a postoperative infection was suspected.It was confirmed that no germ was found.Action taken: unknown.It was not reported if the patient received a corrective treatment for all events.Outcome: unknown.Seriousness criteria: medically significant for hemodynamic failure (circulatory collapse) a product technical compliant was initiated and results were pending for the same.Additional information was received on (b)(6) 2019 form pharmacist.Event of suspected postoperative infection nos was deleted.Clinical course updated.Text amended accordingly.

Event Description

Hemodynamic failure (circulatory collapse) [circulatory collapse].Inflammatory red patches on the skin [skin inflammation] ([skin edema], [erythematous skin rash]).Wound secretion [wound secretion].Case narrative: the case was cross referenced with cases:(b)(4)> initial information received from france on 19-mar-2019 and 25-mar-2019 processed together with clock start date of (b)(6) 2019 regarding an unsolicited valid serious case received from a pharmacist and health authority (reference number: (b)(4).This case involves 1 year old male patient who used medical device carboxymethylcellulose, sodium hyaluronate (seprafilm) and experienced hemodynamic failure (circulatory collapse) (latency: 11 days), inflammatory red patches on the skin (latency: 8 days), wound secretion (latency: 11 days).The patient's past medical history included previous 3 laparotomy and patient had same reactions and each time a germ was found and postoperative infection was suspected.The patient's past medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2019, the patient underwent laparotomy which was the fourth one and was inserted with carboxymethylcellulose, sodium hyaluronate (lot - 8bysep017) for adherence prophylaxis after surgery.On (b)(6) 2019, the patient experienced an erythematous skin rash with inflammatory red patches on the skin, and edemas (latency: 8 days).On (b)(6) 2019 (two or three days later), the patient presented wound secretion and hemodynamic failure (circulatory collapse) (latency: 11 days).Also a postoperative infection was suspected.It was confirmed that no germ was found.Action taken: unknown.It was not reported if the patient received a corrective treatment for all events.Outcome: unknown.Seriousness criteria: medically significant for hemodynamic failure (circulatory collapse).A product technical compliant was initiated on (b)(6) 2019 for seprafilm (lot number 8bysep017) with global ptc number (b)(4).On(b)(6) 2019, product event intake report (peir) (b)(4) was received from france pv regarding a preadverse event (erythematous skin rash).The lot number provided was (b)(6) 2017.(b)(6) 2017: date of manufacture for this lot was 25mar18, expiry date was 2021-03-31.Product event trending shows that there were no other adverse events associated with this specific lot.However, there were 3 other pre-adverse events (erythematous skin rash) which reference this event.Peir (b)(4) are three additional events created by pv for this patient?s three prior surgeries referred to in the intake information.Pv cases are created for each reported event.A catsweb event is initiated for each aegis case number.The lot numbers for these three other peirs (b)(4), are listed as unknown since the lots were not specified.On page 2 of the isi forms submitted for these peirs, the batch field contains "unk?.Therefore, per global operating procedures, a lot number could not be reported.All batch records were reviewed and approved by qa including the fbs-mbr-000083 "heat sealing and packaging of all configurations of seprafilm full, half and quarter sheets at 76nya" and fbs-mbr-000066 "packaging and gamma irradiation of all configurations of seprafilm full, half and quarter sheets at 76nya".All manufacturing process specifications including pouch burst testing, qc release specifications per fbs-spc-000052 (part number 4301-00) and sterility testing were verified to have been met.A lot history review was performed for lot 8bysep017 in the trackwise system.No deviations are associated with this lot (see attached tw deviation lot report).Two change controls were included in 8bysep017 release packet with corresponding memos.(b)(6) 2019:validated heat sealer will be moved into manufacturing and be used in the process.This change was determined to be effective.Per the effectiveness review: the heat sealer was deemed effective for heat sealing the foil pouches to the acceptable burst test levels.Change control was closed (b)(6) 2018.2017fbscc0020 - alternate foil for seprafilm foil pouch.All actions were completed with the exception of one country regulatory approval currently pending.This change was validated under approved protocol.No impact is expected.Per the initial change control request, there are no supposed improvements or corrective measures being evaluated when switching from the current to the proposed foil pouch material.The driver for the foil change is merely a supply issue.Seprafilm adhesion barrier serves as a temporary bioresorbable barrier separating apposing tissue surfaces.The physical presence of the membrane separates adhesiogenic tissue while the normal tissue repair process takes place.When applied as directed, seprafilm adhesion barrier can be expected to reduce adhesions within the abdominopelvic cavity.Approximately 24 to 48 hours after placement, the membrane becomes a hydrated gel that is slowly resorbed within one week.Components are excreted in less than 28 days.Product safety metrics are compiled by sanofi global pharmacovigilance and epidemiology and presented to senior management.Any trending signal is discussed during these trending meetings and escalated to the safety governance for adjudication.The lot was sterilized by gamma irradiation.The certificate of irradiation was reviewed and all dosimeter readings were within the minimum and maximum dose and exposure time required per seprafilm sterility specifications.Nothing was noted in the lot history that would be indicative of a product malfunction.All seprafilm lots manufactured by sanofi-genzyme were released for shipping by quality assurance only after the successful completion of certificate of analysis testing and review of associated process documentation.This release procedure provides assurance that all lots are manufactured under the specified process parameters and meet final product specifications.As no issue was found during batch record review or trending, no capa was considered necessary at this time.Sanofi-genzyme would continue to monitor and trend these types of events and implement appropriate corrective actions where applicable.Additional information was received on 25-mar-2019 form pharmacist.Event of suspected postoperative infection nos was deleted.Clinical course updated.Text amended accordingly.Additional information was received on 11-apr-2019.Ptc results received and processed.Global ptc number added.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• Manufacturer (Section D): GENZYME CORPORATION(FRAMINGHAM); 76 new york avenue; framingham 01701
• MDR Report Key: 8486866
• MDR Text Key: 141059178
• Report Number: 1220423-2019-00007
• 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
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

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: No Information
• Device Lot Number: 8BYSEP017
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 1 YR