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

Catalog Number	5955680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930); Bowel Perforation (2668)
Date of Event	01/11/2015
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-feb-2014) is considered to be a best estimate.This mdr represents the ventralight st using echo ps (device #2).An additional supplemental emdr was submitted to represent the ventralight st using echo ps (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) 2014: patient was diagnosed with ventral hernia thereby underwent laparoscopic repair with implant of ventralight st using echo ps (device #1).Per op notes, ¿a large ventral hernia sac was identified with omentum.A small amount of attached colon was reduced.The omentum was removed completely.A ventralight st using echo ps (device #1) was placed and tacked.¿ (b)(6) 2014: patient was diagnosed with small bowel obstruction with abdominal pain and adhesions thereby underwent laparoscopic repair with implant of ventralight st using echo ps (device #2) and lysis of adhesions.(note: there is no operative notes provided for this procedure).(b)(6) 2015: patient was diagnosed with perforation, infected mesh and hiatal hernia with abdominal pain thereby underwent open repair with excision ventralight st using echo ps (device #1 and #2) and implant of biological mesh.Per operation notes, ¿the free floating fecal and purulent contamination in abdominal cavity were removed and irrigated.A large piece of tacked infected old mesh (device #1 & #2) was identified and removed entirely.A large hiatal hernia defect was identified, excised and repaired using sutures.An 8mm perforation in sigmoid colon was identified and proceed with colostomy.A small ventral hernia was identified, reduced and repaired with sutures.A large biological mesh was placed and sutured.¿ (b)(6) 2015: patient was diagnosed with abdominal wall seroma thereby underwent open repair with drainage of seroma.Per op notes, ¿a large seroma was identified with some red old clots were drained and wound vac was placed and sutured.¿.

• 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: 22673997
• Report Number: 1213643-2025-00696
• Device Sequence Number: 17069296
• Product Code: FTL
• UDI-Device Identifier: 00801741031755
• UDI-Public: (01)00801741031755(17)160228(10)HUYB1006
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 07/23/2025

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: 02/28/2016
• Device Catalogue Number: 5955680
• Device Lot Number: HUYB1006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2014
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 84 KG