MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO; SURGICAL MESH

Catalog Number	5955790
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Unspecified Infection (1930)
Date of Event	04/16/2015
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-nov-2014) is considered to be a best estimate.This emdr represents the ventralight st w/ echo (device 2).An additional supplemental emdr was submitted to represent the sepramesh ip 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.
Event or Problem Description
Per information provided: (b)(6) 2010 - patient was diagnosed with ventral hernia thereby underwent laparoscopic repair with implant of sepramesh ip.Per operative notes, ¿a small incision was made in the right upper quadrant.Adhesions and omentum were removed from abdomen.A sepramesh ip (device 1) was placed into the peritoneal cavity and closed with sorbafix absorbable tackers.¿ (b)(6) 2014 - patient was diagnosed with infected abdominal wall mesh, abscess, fistula, purulent discharge thereby underwent open repair with explant of sepramesh ip (device 1) and drainage of abscess.Per operative notes, ¿an incision was made just above the umbilicus.There was fistula which was removed.There was dense amount of abscess fluid which was drained from abdomen.All purulent fluid which was present into the abscess cavity, were drained.Previously placed mesh sepramesh ip (device 1) was excised entirely.The defect was closed with sutures.¿ (b)(6) 2015 - patient was diagnosed with recurrent ventral incisional hernia, adhesion thereby underwent laparoscopic repair with implant of ventralight st w/ echo mesh (device 2).Per operative notes, ¿a small left subcostal incision was made.There were extensive adhesions to the anterior abdominal wall.Omentum adhesions were taken down.A ventralight st w/ echo mesh (device 2) was placed into the abdominal wall and secure it with sorbafix absorbable tackers.¿ (b)(6) 2015 - patient was diagnosed with mesh infection, abscess, adhesion, purulent discharge thereby underwent open repair with explant of ventralight st w/ echo mesh (device 2).Per operative notes, ¿an upper midline surgical incision was made and carried to the subcutaneous tissue.There was a pocket of purulent fluid to the right of the midline which was drained.Previously placed infected ventralight st w/ echo mesh (device 2) was dissected out.All abscess and adhesions were taken down.The defect was closed with sutures.¿.

• Brand Name: VENTRALIGHT ST W/ ECHO
• 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: 24313181
• Report Number: 1213643-2026-00104
• Device Sequence Number: 12174796
• Product Code: FTL
• UDI-Device Identifier: 00801741031762
• UDI-Public: (01)00801741031762(17)161228(10)HUYK1349
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

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: 12/28/2016
• Device Catalogue Number: 5955790
• Device Lot Number: HUYK1349
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2014
• 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: 63 YR
• Patient Sex: Female