MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD MESH PRE-SHAPED W/ KEYHOLE; SURGICAL MESH

Catalog Number	0112710
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Seroma (2069); Hernia (2240)
Date of Event	02/23/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2002 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of bard flat mesh (device #1).Per operative notes, ¿a very large umbilical hernia was identified.A bard flat mesh (device #1) was placed and sutured.¿ on (b)(6) 2003 - patient was diagnosed with left inguinal hernia thereby underwent open repair with the implant of preshaped mesh w/ keyhole (device #2).Per operative notes, ¿a large sclerotic sac was dissected, and a preshaped mesh w/ keyhole (device #2) was sewn in place at the pubic tubercle and sutured.¿ on (b)(6) 2014 - patient was diagnosed with small bowel obstruction, adhesions and pain thereby underwent open repair.Per operative notes, ¿the omentum was stuck up to the mesh.This was taken down meticulously, and this completely relieved the obstruction.¿ on (b)(6) 2015 - patient was diagnosed with recurrent left inguinal hernia and adhesions thereby underwent laparoscopic repair with the implant of synthetic mesh.Per operative notes, ¿the adhesions were taken down and a synthetic mesh was secured circumferentially using sutures.¿ (there was no visualization/mention of preshaped mesh w/ keyhole (device #2).On (b)(6) 2017 - patient was diagnosed with right inguinal hernia thereby underwent open repair with the implant of synthetic mesh.Per operative notes, ¿the hernia sac was dissected free from the cord structures and a synthetic mesh was placed within the defect and sutured." (there was no visualization/mention of preshaped mesh w/ keyhole (device #2).On (b)(6) 2017 - patient was diagnosed with incisional hernias, intra-abdominal mass/abscess and adhesions thereby underwent open repair.Per operative notes, ¿the hernia sac was dissected free and the mesh from prior repairs were noted.An abscess cavity was found after taken down the purulent material.Once adhesions were removed and hernia repair was performed using sutures.¿ attorney alleged that the patient had abscess, adhesions, bowel obstruction, pain, hernia recurrence and emotional injuries.It was also alleged that the first revision describes a small bowel obstruction with direct evidence of association to the mesh was noted, "the mesh was divided very meticulously, and the omentum was stuck up to the mesh.Running the small bowel revealed a cord measuring several millimeters in diameter to the pelvis, and this was excised in toto.This completely relieved the obstruction." the second modification of bard mesh on (b)(6) 2017 the path report for the infected mesh showed foreign body reaction.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, post implant of bard mesh pre-shaped w/ keyhole, patient was diagnosed with hernia recurrence, seroma and adhesions thereby underwent repair.The instructions-for-use supplied with the device lists hernia recurrence, seroma and adhesions as possible complications.This emdr represents bard mesh pre-shaped w/ keyhole (device #2).An additional supplemental emdr was submitted to represent bard flat mesh (device #1).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.H3 other text: not returned.

• Brand Name: BARD MESH PRE-SHAPED W/ KEYHOLE
• 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: 21282061
• Report Number: 1213643-2025-090049
• Device Sequence Number: 15782956
• Product Code: FTL
• UDI-Device Identifier: 00801741016554
• UDI-Public: (01)00801741016554
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2025

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: 0112710
• Device Lot Number: 43AND238
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 01/31/2025
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 79 KG