MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 MESH ¿ COMPOSIX L/P; SURGICAL MESH

Catalog Number UNKAA017

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)

Event Date 01/01/2002

Event Type  Injury  

Event Description

Per journal article: "laparoscopic incisional hernia repair after liver transplantation long-term series and literature review": purpose: to perform a retrospective analysis of outcomes in patients who underwent laparoscopic hernia repair after liver transplantation (lt) since 1998 and to review all published studies of the laparoscopic approach to hernia repair after lt.Conclusion: laparoscopic hernia repair in patients with previous lt is safe with a low complication rate and is reproducible and therefore, should be the first-choice approach.Between 2002 and 2018, 37 patients underwent laparoscopic hernia repair surgery after lt, with placement of intraperitoneal mesh - composix l/p mesh (22 patients), ventralight st (11 patients), others (4 patients) fixed with non-resorbable tackers.Post-op complications included seroma (3 patients), wound infection (1 patient), hernia recurrence (2 patients).Article does not provide case/product specific information to know which patient were implanted with what device and experienced what complications.

Manufacturer Narrative

Based on the information available, no conclusions can be made.Seroma, infection, and hernia recurrence are known inherent risks of surgery/use of the device.Seroma and hernia recurrence are included as possible complications in the adverse reactions section of the instructions-for-use (ifu), supplied with the device.In regard to infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." no lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event ((b)(6) 2002) is provided as an estimate based on the information provided.This mdr represents the mesh ¿ composix l/p.Additional mdr was submitted to represent the ventralight st mesh.Not returned.

• Brand Name: MESH ¿ COMPOSIX L/P
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 16240115
• MDR Text Key: 308090202
• Report Number: 1213643-2023-00013
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K061754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• 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
• Patient Outcome(s): Required Intervention