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

Catalog Number	0112680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	02/03/2016
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-mar-2013) is considered to be a best estimate.This emdr represents the bard flat mesh (device 2).An additional supplemental emdr was submitted to represent the 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.
Event or Problem Description
Per information provided: on (b)(6) 2013 - patient was diagnosed with ventral hernia x 2 thereby underwent open repair with implant of bard flat mesh.Per op notes, "a periumbilical incision was made.The hernia sac was identified and reduced.The excess sac was excised.A piece of bard flat mesh (device 1) was placed in the plane between the peritoneum and fascia and secured in place with sutures.Another incision was made over the supraumbilical hernia.The hernia sac was identified and dissected free.The sac was opened and contained fat.The hernia defect was enlarged to allow reduction of the fat.Excess fat was excised and the peritoneum was closed with suture.Another piece of bard flat mesh (device 2) was placed in the plane between the peritoneum and fascia and secured in place with sutures." on (b)(6) 2016 - patient was diagnosed with incarcerated incisional hernia thereby underwent laparoscopic repair with implant of synthetic mesh.Per op notes, "omental adhesions to the midline abdominal wall superiorly with small bowel adhesions to the inferior aspect of the incision into the right abdominal wall was noted and adhesions were lysed.Omental adhesions to the upper aspect of the line were taken down.Chronically incarcerated omental content was reduced from several small hernia defects.Small bowel adhesions to the inferior aspect of the midline as well as the right abdominal wall were taken down.The hernia defect extended to the falciform ligament was taken down from the abdominal wall.A synthetic mesh was placed and secured to the abdominal wall with absorbable tack and 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: 25595852
• Report Number: 1213643-2026-00787
• Device Sequence Number: 5443328
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530(17)180328(10)HUXC0432
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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: 03/28/2018
• Device Catalogue Number: 0112680
• Device Lot Number: HUXC0432
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2013
• 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: 32 YR
• Patient Sex: Male