MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD FLAT MESH; SURGICAL MESH

Catalog Number UNKAA030

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Unspecified Infection (1930); Sepsis (2067); Bowel Perforation (2668)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

As reported, the patient experienced chronic infection, erosion, sepsis and underwent multiple surgeries post-implant of the bard/davol marlex mesh (bard flat mesh).This event was reported via a health canada incident report.Due to privacy laws in (b)(6)patient details are unobtainable, as such we are unable to request additional details regarding the patient¿s outcome.Based on the information provided, no conclusion can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.In regards to the infection, the warnings section of the instructions for use (ifu) states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.Unresolved infection may require removal of the mesh." note, the date of event is provide based on the date of awareness of the reported event.Should additional information be provided, a supplemental mdr will be submitted.Not returned.

Event Description

The following was reported via (b)(6) incident report (#(b)(4)): it was reported that on (b)(6) 1993, the patient was implanted with an unspecified bard/davol ¿marlex hernia mesh¿ (bard flat mesh) and used for approximately 27 years.¿the marlex mesh made by bard caused chronic infection and ruptured the small bowel until he had over 20 operations from the mesh growing through his abdominal wall making holes in his gi tract and causing sepsis, and destroyed every organ in his pelvic area.¿.

• Brand Name: BARD FLAT MESH
• 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: 11338241
• MDR Text Key: 232210087
• Report Number: 1213643-2021-20031
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• 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): Life Threatening; Required Intervention