MAUDE Adverse Event Report: ETHICON INC. NUROLON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC

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

Patient Problem Wound Dehiscence (1154)

Event Type  Injury  

Event Description

Title: component separation: a case report of hybrid and synthetic absorbable mesh use for complex large ventral hernia reparation.This study presents a case report of a 50-yearold male patient with a large (>18 cm) abdominal wall defect.A two-stage surgery was planned, with the first being a diagnostic laparoscopy with air insufflation followed by stage two-component separation surgery.0-vicryl (ethicon/j&j, bridgewater, nj), 2-0 vicryl plus sutures, 2-0 neurolon, 2-0 pds (ethicon), and 3-0 prolene sutures were used.One-month follow-up revealed a slight dehiscence in the periumbilical area with visible granulation tissue.The second wound dehiscence occurred at the 90 days postoperative follow-up.We report a case that used the double underlay and onlay mesh technique with a hybrid mesh under the muscle bridging the gap and progressive tension sutures placed on the fascia overlying the rectus, which was then reinforced with a synthetic nonhybrid absorbable mesh.

Manufacturer Narrative

(b)(4).Date sent to fda: 5/3/2023 this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.H6 component code: g07002 ¿ device not returned.Related events captured via 2210968-2023-03242, 2210968-2023-03243, 2210968-2023-03244, and 2210968-2023-03246 citation: bafitis h, arboleda v, bernal i (march 19, 2023) component separation: a case report of hybrid and synthetic absorbable mesh use for complex large ventral hernia reparation.Cureus 15(3): e36347.Https://doi.Org/10.7759/cureus.36347.

• Brand Name: NUROLON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16862715
• MDR Text Key: 314494761
• Report Number: 2210968-2023-03245
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2023
• 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
• Treatment: PHASIXTM ABSORBABLE NONHYBRID MESH
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male