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

Catalog Number	0117009
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hernia (2240)
Date of Event	12/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-feb-2011) is considered to be a best estimate.This emdr represents the bard soft mesh (device 7).Additional supplemental emdrs were submitted to represent the bard perfix plugs (device 1, 2, 3, 4, 5, 6).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.
Event or Problem Description
Per information provided: on (b)(6) 2011- patient was diagnosed with large incarcerated left inguinal hernia, large defect in left lower quadrant, thereby underwent open repair with implant of perfix plugs (device 1, 2, 3, 4, 5, 6), bard soft mesh (device 7).Per op notes, "a large hernia noted and palpable in the left groin with omentum in left hemiscotum.A large hernia defect in left lower quadrant with hernias in the floor of left inguinal canal.An indirect hernia was also noted in the left inguinal region.There were large direct and indirect hernias in the floor of left inguinal area.These hernia sacs were carefully dissected.The hernia contents were reduced.An extra-large perfix plugs (device 1, 2, 3, 4, 5, 6) were superiorly to the conjoined tendon and were sutured together.Another hernia in floor of the left inguinal region was identified and repaired by placing a bard soft mesh (device 7) and sutured." on (b)(6) 2016- patient had abdominal pain.On (b)(6) 2018- patient had hernia repair.On (b)(6) 2021- patient was diagnosed with recurrent left inguinal hernia, pain, thereby underwent robotic assisted laparoscopic repair with explant of perfix plugs (device 1, 2, 3, 4, 5, 6), bard soft mesh (device 7) and implant of synthetic mesh.Per op notes, "fibrosis from the perfix plugs were noted.All old meshes were excised.A synthetic mesh was placed covering the whole defect and sutured.".

• Brand Name: BARD SOFT MESH
• Common Device Name: 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: 25657715
• Report Number: 1213643-2026-00811
• Device Sequence Number: 15834281
• Product Code: FTL
• UDI-Device Identifier: 00801741030864
• UDI-Public: (01)00801741030864(17)160328(10)HUVB2198
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2026

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 Expiration Date: 03/28/2016
• Device Catalogue Number: 0117009
• Device Lot Number: HUVB2198
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2011
• 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: 54 YR
• Patient Sex: Male