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

Catalog Number	5954460
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the ventralight st mesh was implanted incorrectly with the st coated side oriented against the abdominal wall instead of facing the bowel as intended.It appears that the postoperative issue that presented was due to the incorrect placement of the implant.No lot number has been provided; therefore, a review of the manufacturing records is not possible.The instructions-for-use, supplied with the device, states, ¿it is extremely important that this mesh be oriented correctly to function as intended.The visceral side of ventralight st mesh is designed to temporarily separate tissue surfaces and minimize tissue attachment to the mesh.Place the bioresorbable, coated side of the mesh against those surfaces where minimal tissue attachment is desired, i.E., against bowel or other visceral structures.The uncoated polypropylene mesh side should face the surface where tissue ingrowth is desired.The uncoated polypropylene mesh side should never be placed against the bowel or other visceral structures¿.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
As reported, using the scroll technique the ventralight st mesh was implanted on the wrong/reversed side (st coated side oriented against the abdominal wall instead of facing the bowel.) postoperatively the patient was diagnosed with ileus.
Event or Problem Description
As reported, using the scroll technique the ventralight st mesh was implanted on the wrong/reversed side (st coated side oriented against the abdominal wall instead of facing the bowel.) postoperatively the patient was diagnosed with ileus.
Additional Manufacturer Narrative
As reported, the ventralight st mesh was implanted incorrectly with the st coated side oriented against the abdominal wall instead of facing the bowel as intended.It appears that the postoperative issue that presented was due to the incorrect placement of the implant.No lot number has been provided; therefore, a review of the manufacturing records is not possible.The instructions-for-use, supplied with the device, states, ¿it is extremely important that this mesh be oriented correctly to function as intended.The visceral side of ventralight st mesh is designed to temporarily separate tissue surfaces and minimize tissue attachment to the mesh.Place the bioresorbable, coated side of the mesh against those surfaces where minimal tissue attachment is desired, i.E., against bowel or other visceral structures.The uncoated polypropylene mesh side should face the surface where tissue ingrowth is desired.The uncoated polypropylene mesh side should never be placed against the bowel or other visceral structures.¿ addendum: h11: this supplemental mdr is submitted to correct the implant date field.Updated fields: b4, g3, g6, h2, h10, h11.Corrected field: d.6 a (medical device implant date).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: VENTRALIGHT ST MESH
• 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: 21646622
• Report Number: 1213643-2025-00208
• Device Sequence Number: 7564847
• Product Code: FTL
• UDI-Device Identifier: 00801741031625
• UDI-Public: (01)00801741031625
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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 Catalogue Number: 5954460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown