MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETENE; MESH, SURGICAL, POLYMERIC

Model Number PPL3030

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)

Patient Problems Wound Dehiscence (1154); Tissue Damage (2104); Hernia (2240); Injury (2348); Blood Loss (2597); No Code Available (3191)

Event Date 10/29/2017

Event Type  Injury  

Manufacturer Narrative

The incident sample was requested but to date has not been received for evaluation.If the sample or additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, following a large incisional hernia repair procedure for an abdominal hernia repair the surgeon used an open approach using suture for fixation and wound closure.The patient came back with a recurrence where the mesh had split down the middle.The mesh had to be explanted from the patient and as a result there was some tissue loss and damage.A new mesh was implanted to repair the defect.The incision was extended due to the product problem and the patient remained at the post-operative care of the hospital.The patient is alive with and recovering from the injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, per additional information received the event occurred post operatively ,the patient originally had a hernia operated on the (b)(6) and the dressing that was used was opside.The dressing had failed and they went to a local clinic where they went to change the dressing and skin came off with it.The patient then presented to the emergency department with wound break down , dehiscence and they needed to debride the wound.It was at emergency where they realized that the patient needed to be operated on and when the re operated they realized it was a recurrence.As mentioned the surgeon who removed the mesh said it looked like the mesh was ripped apart.The sutures were still intact.The surgeon who looked after the patient the second time was different to the first.The reoperation date was the (b)(6), no ct scan was needed.Surgery was done on the day of presentation at emergency.The mesh used to repair is from another manufacturer.The patient was taken to icu after the operation to repair the recurrence; and discharged to a ward on the (b)(6) and they are still in hospital.There was no blood loss greater than 500 cc¿s and it did extended surgical time greater than 30 minutes.The incision was extended greater than 1 inch.The mesh was not cut prior to implementation and the appearance of the mesh was wet bloody and it was as if someone ripped it in half with the sutures still attached.The patient was alive with injury.Currently the patient is still in hospital waiting for the wound to heal.

• Brand Name: PARIETENE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 7049793
• MDR Text Key: 92658776
• Report Number: 9615742-2017-05819
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K991400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: PPL3030
• Device Catalogue Number: PPL3030
• Device Lot Number: SQL0805X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2017
• Date Device Manufactured: 01/11/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 86