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

Catalog Number	0117016
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	11/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2000 - patient was diagnosed with incarcerated incisional ventral hernia thereby underwent open repair with implant of bard flat mesh (device 1).Per op notes, ¿an infraumbilical incision was made over the underlying mass.A complex hernia with multiple cavities of hernia sac with incarcerated omentum was identified.Some of the omentum was resected.Numerous holes in the fascia causing a long defect were noted and repaired with sutures.A bard flat mesh (device 1) was placed and secured with sutures.¿ (b)(6) 2014 - patient was diagnosed with large recurrent ventral hernia thereby underwent open repair with implant of bard soft mesh (device 2).Per op notes, ¿previous midline incision was opened.A transverse incision was made above the groin crease.The hernia sac was identified and the contents were moved.The previous mesh had torn loose and was incorporated in parts of the hernia sac.The scar over the previous midline incision and all the hernia sac was then excised.A bard soft mesh (device 2) was placed and secured with sutures.A drain was placed and the skin was closed with an absorbable stitches.¿ (b)(6) 2018 - patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic converted to robotic assisted repair with implant of ventralight st mesh (device 3 and 4).Per op notes, ¿dense adhesions and extensive adhesions were identified along the abdominal wall and were lysed.The defect was noted on the right lateral abdominal wall.An additional defect near to this and a midline suprapubic defect were also noted.All the defects contained incarcerated omentum and were reduced.All the defects were primarily repaired with sutures.A ventralight st mesh (device 3 and 4) were placed to the abdominal wall and secured with sutures.¿.
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.This mdr represents the bard soft mesh (device 2).An additional supplemental emdr was submitted to represent the bard flat mesh (device 1).Note, the manufacturing date (15-nov-2013) is considered to be a best estimate.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.

• 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: 24543087
• Report Number: 1213643-2026-00293
• Device Sequence Number: 5724759
• Product Code: FTL
• UDI-Device Identifier: 00801741030932
• UDI-Public: (01)00801741030932(17)190128(10)HUXK1664
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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: 01/28/2019
• Device Catalogue Number: 0117016
• Device Lot Number: HUXK1664
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2013
• 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: 45 YR
• Patient Sex: Female