MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Bard Flat Mesh; Surgical Mesh

Catalog Number	0112640
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	07/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2014 - patient was diagnosed with incarcerated umbilical hernia and incisional hernia at port site thereby underwent laparoscopic repair with implant of bard flat mesh (device 1 and 2).Per op notes, ¿incision was made just lateral to the port site hernia in the left mid quadrant.Some adhesions were lysed.Lap-band was excised.The port site hernia was noted and reduced.A bard flat mesh (device 1) was placed and sutured.An infraumbilical incision was made.The umbilical defect was identified in the supraumbilical area with incarcerated omental fat was reduced.Reductant omentum resected.Hernia contents were reduced.A bard flat mesh (device 2) was placed and sutured.¿ (b)(6) 2017 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with implant of ventrio st (device 3).Per op notes, ¿a vertical laparotomy incision was made just below the level of xiphoid process to just beneath the umbilicus.Multiple hernia sacs were identified.The largest sac was mobilized down.The remaining hernia sac were opened and excised.The incarcerated omentum was reduced.Extensive lysis of adhesions was performed.Multiple loops of small bowel and colon were reduced.Multiple pieces of prior mesh (device 1 and 2) were noted.A ventrio st (device 3) was placed and tacked.¿.
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 bard flat mesh (device 1).Note, the manufacturing date (15-may-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 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 ; +1(800)556-6756
• MDR Report Key: 50945175
• Report Number: 1213643-2026-01262
• Device Sequence Number: 16039393
• Product Code: FTL
• UDI-Device Identifier: 00801741016493
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: Preamendment
• 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): 09/23/2026

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: 06/28/2018
• Device Catalogue Number: 0112640
• Device Lot Number: HUXE1687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2013
• 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 Sex: Female