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

Catalog Number	0112660
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Necrosis (1971); Hernia (2240)
Date of Event	12/05/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 2 years 11 months post implant of bard flat mesh, patient was diagnosed with hernia recurrence, adhesions and necrosis thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.This emdr represents the bard flat mesh (device #6).Additional supplemental emdr's were submitted to represent the bard flat mesh (device #2, device #4 & device #5) and additional emdr's were submitted to represent the bard flat mesh (device #1, device #3, device #7).Note: section a through f - the information provided by bd 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 bd.Not returned.
Event or Problem Description
Per information provided: (b)(6) 2009 - patient was diagnosed with large left incisional hernia thereby underwent open repair with the explant of bard flat mesh (device #1) and implant of bard flat mesh (device #2 & #3).Per operative notes, ¿hernia sac was excised.A marlex mesh (device #2 & #3) was placed and attached to the fascia using sutures.Protruding prolene sutures and marlex mesh (device #1) were excised.¿ (there was no implant operative notes provided for bard flat mesh (device #1)).(b)(6) 2009 - patient was diagnosed with left incisional hernia thereby underwent open repair with the implant of bard flat mesh (device #4).Per operative notes, ¿hernia sac was excised and small bowel was reduced back into the peritoneal cavity.A marlex mesh (device #4) was placed and attached to the fascia using staples.¿ (there were no visualization/mention of bard flat mesh (device #2 & device #3).(b)(6) 2011 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of bard flat mesh (device #5 & device #6) and partial explant of bard flat mesh (device #2, device #3 & device #4).Per operative notes, ¿a large hernia defect was noted towards the right side of the mid lower abdomen.Once the lysis of adhesions and hernia sac were excised.A large marlex mesh (device #5) was placed and attached to the fascia using staples.Previously placed marlex mesh (device #2, device #3 & device #4) appeared to be pulled out from the side and the portions of the meshes were excised.Subsequently, another marlex mesh (device #6) was placed and attached to the fascia using staples.¿ (b)(6) 2013 - patient was diagnosed with large upper mid incisional hernia thereby underwent open repair with the implant of bard flat mesh (device #7) and removal of bard flat mesh (device #2, #3, #4, #5 #6).Per operative notes, ¿marlex mesh (device #2, #3, #4, #5 #6) were identified on the mid portion of the hernia sac.Extensive lysis of adhesions and marlex mesh (device #2, #3, #4, #5 #6) were removed.Then a marlex mesh (device #7) was placed and attached to the fascia using staples.¿ (b)(6) 2016 - patient was diagnosed with mid abdominal incisional hernia thereby underwent open repair with partial removal of bard flat mesh (device #7).Per operative notes, ¿adhesions in the abdominal cavity were taken down and large hernia defect was identified.Previously placed marlex mesh (device #7) which incorporated with fascia was transected.The marlex mesh (device #7) and fascia were tied together using sutures.¿ attorney alleged that the patient had adhesions, pain and hernia recurrence.

• Brand Name: BARD FLAT MESH
• Common Device Name: 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 21373204
• Report Number: 1213643-2025-090079
• Device Sequence Number: 17100376
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0112660
• Device Lot Number: 43DQD056
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female