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	Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	01/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6)2016 ¿ patient was diagnosed with umbilical hernia thereby underwent laparoscopic repair with implant of bard soft mesh (device 1).Per operative notes, ¿a piece of bard soft mesh (device 1) was placed into the retrorectus space and sutured.¿ (b)(6)2016 ¿ patient was diagnosed with small bowel obstruction and recurrent hernia thereby underwent laparoscopic repair with implant of ventralight st using echo ps (device 2).Per operative notes, ¿a ventralight st using echo ps (device 2) was placed into the abdomen and attach it to the anterior abdominal wall and tacked.¿ (b)(6)2018 ¿ patient was diagnosed with multiply recurrent incisional hernia thereby underwent open repair with partial removal of (device 1 and device 2).Per operative notes, ¿the retrorectus piece of mesh and intraperitoneal mesh was noted.Both pieces of mesh were cut in half.Adhesions were lysed.The mesenteric border of the bowel was scarred.A piece of synthetic mesh was placed and secured using 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.Note, the manufacturing date (15-may-2016) is considered to be a best estimate.This mdr represents the bard soft mesh (device 1).An additional supplemental emdr was submitted to represent the ventralight st using echo ps (device 2).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: 23321052
• Report Number: 1213643-2025-00996
• Device Sequence Number: 18619270
• Product Code: FTL
• UDI-Device Identifier: 00801741030932
• UDI-Public: (01)00801741030932(17)210428(10)HUAS0433
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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: 04/28/2021
• Device Catalogue Number: 0117016
• Device Lot Number: HUAS0433
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2016
• 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: 33 YR
• Patient Sex: Female