MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD SOFT MESH PRE-SHAPED W/ KEYHOLE; SURGICAL MESH

Catalog Number	0117015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2009 ¿ patient was diagnosed with right incisional hernia thereby underwent open repair with implant of perfix plug (device 1).Per operative notes, ¿the incisional hernia was identified and a perfix plug (device 1) was placed into the caesarean hole and an onlay mesh was placed on top and sewed it to the conjoined tendon.¿ (b)(6) 2018 ¿ patient was diagnosed with chronic abdominal pain in the lower abdomen thereby underwent laparoscopic repair.Per operative notes, ¿a large amount of omental type adhesions in the lower abdominal area were taken down.A perfix plug (device 1) in the right lower quadrant that is sticking into the abdominal area which was causing a chronic pain.¿ (b)(6) 2018 ¿ patient had lower abdominal pain and diagnosed with abdominal wall seroma thereby underwent incision and drainage of seroma.(b)(6) 2018 ¿ patient was diagnosed with chronic abdominal wall pain, meshoma and ventral hernia thereby underwent open repair with the removal of mesh (device 1) and implant of pre-shaped soft mesh (device 2).Per operative notes, ¿a meshoma was identified.The previous mesh (device 1) that had curled up into a ball was removed.The resulting abdominal wall defect was closed primarily using sutures.An onlay repair was performed in the right groin using a pre-shaped soft mesh (device #2) and secured using sutures.¿ (b)(6) 2019 ¿ patient was diagnosed with recurrent large incarcerated right inguinal hernia; lower abdominal adhesions thereby underwent robotic repair with the partial removal of mesh (device 2).Per operative notes, ¿adhesions were lysed.The hernia defect was identified and found to be partially lined by an old mesh that appeared to be polypropylene (device 2).The hernia sac was separated from underlying mesh in some areas while portion of the mesh (device 2) was excised.A synthetic mesh was placed into the peritoneal cavity.¿.
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-2017) is considered to be a best estimate.This emdr represents the bard soft mesh pre-shaped w/ keyhole (device 2).An additional supplemental emdr was submitted to represent the bard perfix plug (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.

• Brand Name: BARD SOFT MESH PRE-SHAPED W/ KEYHOLE
• 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: 23002467
• Report Number: 1213643-2025-00818
• Device Sequence Number: 21034209
• Product Code: FTL
• UDI-Device Identifier: 00801741030925
• UDI-Public: (01)00801741030925(17)220528(10)HUBS2110
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2025

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: 05/28/2022
• Device Catalogue Number: 0117015
• Device Lot Number: HUBS2110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2017
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 88 KG