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

Catalog Number	5955680
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Bowel Perforation (2668)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2017 - patient was diagnosed with multiple incisional hernias thereby underwent laparoscopic repair with the implant of two ventralight st using echo ps (device #1 & #2).Per operative notes, ¿two hernias were noted at the umbilicus and infra umbilicus location.Incarcerated omentum and small bowel were taken out of the multiple hernias.The ventralight st using echo ps (device #1 & #2) was placed in the abdominal cavity and tacked by sutures.¿ on (b)(6) 2017 - patient was diagnosed with small bowel perforation thereby underwent exploratory laparoscopic repair with explant of ventralight st using echo ps (device #1 & #2) and implant of biological mesh.Per operative notes, ¿the hernia sac was noted.The ventralight st using echo ps (device #1 & #2) was removed entirely.Defect in small bowel was noted.A biological mesh was placed in an underlay manner posterior to fascia, then secured by sutures.¿ attorney alleges that the patient had bowel obstruction, bowel perforation, infection, pain and suffering.
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-2017) is considered to be a best estimate.This emdr represent the bard/davol ventralight st w/ echo (device #2).An additional supplemental emdr was submitted to represents the bard/davol ventralight st w/ echo (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.H3 other text : not returned.

• 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 ; 4018258495
• MDR Report Key: 21959708
• Report Number: 1213643-2025-090200
• Device Sequence Number: 18460080
• Product Code: FTL
• UDI-Device Identifier: 00801741031755
• UDI-Public: (01)00801741031755(17)190228(10)HUBP1151
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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: 02/28/2019
• Device Catalogue Number: 5955680
• Device Lot Number: HUBP1151
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Female