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

Catalog Number 0112730

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Hernia (2240)

Event Date 01/12/2006

Event Type  Injury  

Manufacturer Narrative

Per patient medical records, post 2005 implant of the bard/davol dart mesh, the patient experienced a recurrent hernia in 2006 and underwent surgical intervention, at which time an additional non-bard/davol mesh was placed.During a subsequent 2009 procedure for the repair of another recurrent hernia the medical records note the explant of a torn previously placed hernia mesh.There is no indication in the jan2006 operative report that the previously 2005 implanted bard/davol dart mesh was encountered during the ¿recurrence¿ repair.In addition, the initial reporter limited the adverse event allegation claim to the 2006 implanted non-bard/davol mesh and did not make any allegation of adverse event related to the bard/davol dart mesh.Though not discernable from the limited hernia location descriptions in the operative reports, it is possible that the 2006 ¿recurrence¿ repair is in a noticeably identifiable location in relation to the initial 2005 bard/davol dart mesh hernia repair site.However, based on the provided operative reports, it remains unclear which previously implanted mesh was alleged to have torn and was explanted during 2009 index procedure.Based on the information available, no conclusions can be made.Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reactions section of the instructions-for-use supplied with the device as a possible complication.Review of manufacturing records indicates product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.Should additional information be provided, a supplemental mdr will be submitted.Mesh explanted.

Event Description

Per medical records: on (b)(6) 2005 patient underwent repair of an epigastric hernia with implant of a bard/davol dart mesh.On (b)(6) 2006 the patient underwent repair of a recurrent epigastric hernia with implant of a non bard/davol manufactured sepramesh ip.The operative report does not indicate that the previously implanted dart mesh was encountered during this repair.On (b)(6) 2009 the patient underwent repair of a recurrent incisional ventral hernia with implant of a non-bard/davol biologic mesh.The operative report states that during this procedure an "incarcerated torn hernia mesh" was encountered which was explanted during the procedure.

• Brand Name: MESH DART
• 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: 12490903
• MDR Text Key: 272655000
• Report Number: 1213643-2021-20333
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016578
• UDI-Public: (01)00801741016578
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2005
• Device Catalogue Number: 0112730
• Device Lot Number: 43IKD356
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2000
• 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
• Patient Age: 42 YR