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

Catalog Number	0112640
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	04/22/2015
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.This mdr represents the bard flat mesh (device 2).An additional supplemental emdr was submitted to represent the composix mesh (device 1).An additional emdr was created to represent the composix mesh (device 3) in gcs.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) 2002 ¿ patient was diagnosed with abdominal wall hernia containing incarcerated omentum, a second epigastric abdominal wall hernia thereby underwent open repair with the implant of composix mesh (device 1).Per op notes, ¿the hernia sac and hernia contents were encountered in midline and additional defect was found inferior to previous hernia was connected.A bard composix mesh (device 1) was cut to fit the defect and sutured to inner surface of fascial margin.The hernia in epigastrium was noted and closed using sutures.¿ on (b)(6) 2006 ¿ patient underwent implant of bard flat mesh (device 2) and bard composix mesh (device 3).Per pathology report, ¿the hernia sac was dissected from epigastric and lower abdominal area.¿ (note: there is no op notes provided for this procedure in medical records) on (b)(6) 2015 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with the partial removal of composix mesh (device 1, 3).Per op notes, ¿the mesh (device 1) in the midline which was encountered.The mesh was detached from the fascia.The mesh had significant number of adhesions of both bowel and omentum on the internal surface.A portion of redundancy in mesh (device 1, 3) was removed.The fascia in right lateral abdominal wall was noted.The mesh was reapproximated with abdominal wall using sutures.¿ on (b)(6) 2017 ¿ patient was diagnosed with recurrent incarcerated hernia thereby underwent laparoscopic repair with the implant of synthetic mesh.Per op notes, ¿patient had multiple dense adhesions from the previous ventral hernia repair.A large fascial defect identified in the lower portion of her previous incision.The previous mesh (device 1, 2, 3) was noted.A piece of synthetic mesh was placed into peritoneal cavity and secured using sutures.¿ on (b)(6) 2019 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair.Per op notes, ¿the defect was palpable on the right lower quadrant to the right of midline incision.The hernia sac was identified.There was mesh circumferentially around the hernia defect which appeared that the prior mesh (device 1, 2, 3) had come loose from its medial attachment.The mesh was well incorporated and some filmy adhesions from the omentum were taken down.The existing mesh in an underlay type fashion was reattached to the medial aspect using sutures.¿.

• Brand Name: BARD FLAT 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: 25163530
• Report Number: 1213643-2026-00628
• Device Sequence Number: 8569793
• Product Code: FTL
• UDI-Device Identifier: 00801741016493
• UDI-Public: (01)00801741016493(10)43JPD205
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K251557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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 Catalogue Number: 0112640
• Device Lot Number: 43JPD205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Weight: 78 KG