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

Catalog Number	0112740
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	02/22/2012
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-oct-2009) is considered to be a best estimate.This emdr represents the bard mesh - dart (device #1).Additional supplemental emdrs were submitted to represent the bard ventralight st (device #2) and bard ventralight st (device #3).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) 2010 - patient was diagnosed with incarcerated ventral hernia thereby underwent open repair with the implant of dart mesh (device #1).Per operative notes, ¿incarcerated epigastric hernia was identified, and the omentum was reduced in the peritoneal cavity.A large dart mesh (device #1) was placed and secured over the bowel and omentum using sutures.¿ on (b)(6) 2012 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of ventralight st (device #2) and removal of dart mesh (device #1).Per operative notes, ¿previously placed dart mesh (device #1) was removed.Then a large hernia defect was identified.A ventralight st (device #2) was used for repair and secured by sutures.¿ on (b)(6) 2014 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of ventralight st (device #3) and explant of ventralight st (device #2).Per operative notes, ¿previously placed ventralight st mesh (device #2) was removed.Then a ventralight st (device #3) was used for repair and secured in a subfascial plane using sutures.¿ on (b)(6) 2017 - patient was diagnosed with recurrent incisional hernia and adhesions thereby underwent laparoscopic repair with removal of ventralight st (device #3).Per operative notes, ¿ventralight st mesh (device #3) was removed.Once the adhesions were taken down, a synthetic mesh was placed inside the abdominal cavity and tacked in place.¿.

• Brand Name: MESH - DART
• 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: 22380499
• Report Number: 1213643-2025-00547
• Device Sequence Number: 9436762
• Product Code: FTL
• UDI-Device Identifier: 00801741016585
• UDI-Public: (01)00801741016585(17)141130(10)HUTJ0657
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

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: 11/30/2014
• Device Catalogue Number: 0112740
• Device Lot Number: HUTJ0657
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2009
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 63 KG