MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX; SURGICAL MESH

Catalog Number 0115311

Device Problem No Apparent Adverse Event (3189)

Patient Problem Not Applicable (3189)

Event Date 05/26/2017

Event Type  Injury  

Manufacturer Narrative

As reported during the revision procedure it was discovered that the patient did not have a hernia recurrence.What was thought to be a recurrence on the ct was in fact a seroma that did not have any association to the mesh.The mesh remains implanted and intact.This mdr represents the bard 3dmax mesh implanted on the patient's left side, an additional mdr was submitted to represent the right sided repair.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Remains implanted.

Event Description

It was reported that the patient underwent bilateral inguinal hernia repair and was implanted with one right and one left bard 3dmax mesh.An interrupted vicryl stitch was placed medially on both devices.The right side hernia was a larger direct hernia.As reported this was a very routine procedure with no identifiable complications and this was the surgeon¿s first time using the 3dmax mesh.Approximately, 30 days post implant the patient presented with bilateral inguinal hernia recurrence, reported to have been confirmed via ct scan.On (b)(6) 2017 the patient underwent a revision procedure, during the procedure it was determined that the patient in fact did not have any hernia recurrence and both mesh were in place and intact.As reported what was thought to be a recurrence on the ct was in fact a seroma that did not have any association to the mesh.The seroma was drained, and the mesh was left in its original position.This serious injury mdr is filed to document that the patient underwent additional surgery.

• Brand Name: 3DMAX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6644060
• MDR Text Key: 77650591
• Report Number: 1213643-2017-00356
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0115311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• 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