MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Ventralight ST w/ Echo 2; Surgical Mesh

Catalog Number	5990015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Urticaria (2278)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent implant of ventralight st w/ echo 2 on (b)(6) 2025.Post implant the patient developed hives and had abdominal pain which has not resolved.Reportedly, the surgeon was able to obtain mesh for reactivity testing.
Event or Problem Description
As reported, the patient underwent implant of ventralight st w/ echo 2 on (b)(6)2025.Post implant the patient developed hives and had abdominal pain which has not resolved.Reportedly, the surgeon was able to obtain mesh for reactivity testing.
Additional Manufacturer Narrative
As reported, the patient developed hives and had abdominal pain post implant of ventralight st w/ echo 2 mesh.Sample mesh was obtained by the surgeon for reactivity testing however at this time the testing has not been scheduled.No conclusions can be made at this time.If/when reactivity test results are provided, a supplemental mdr will be submitted.The adverse reactions section of the instructions-for-use supplied with the device lists allergic reaction and pain as possible complications.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 116 units.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.
Additional Manufacturer Narrative
As reported, the patient developed hives and had abdominal pain post implant of ventralight st w/ echo 2 mesh.Sample mesh was obtained by the surgeon for reactivity testing however at this time the testing has not been scheduled.No conclusions can be made at this time.If/when reactivity test results are provided, a supplemental mdr will be submitted.The adverse reactions section of the instructions-for-use supplied with the device lists allergic reaction and pain as possible complications.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4)units.Addendum: h11: this is an addendum to the initial mdr submitted to correct the initial reporter state, zip and to update the initial reporter occupation.Updated fields: b4, e3 (initial reporter occupation), g3, g6, h2, h6, h10, h11.Corrected fields: e1 (initial reporter state & initial reporter zip).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 w/ Echo 2
• 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 ; +1(800)556-6756
• MDR Report Key: 50258077
• Report Number: 1213643-2026-01039
• Device Sequence Number: 10135116
• Product Code: FTL
• UDI-Device Identifier: 00801741130991
• UDI-Public: (01)00801741130991(11)250124(17)261128(10)HUKN1241
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2026

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 Catalogue Number: 5990015
• Device Lot Number: HUKN1241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2025
• 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: Other
• Patient Sex: Female