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

Catalog Number	5954460
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	08/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the article, no definitive conclusions can be drawn.The information is limited to what is reported in the article.The article does not report any specific device malfunction or alleged post-op complications were caused or contributed to the use of the ventralight st mesh.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Seroma formation is a clinically understood potential complication of surgery/use of the device and is identified in the instructions-for-use provided with the device, as a possible complication.Note, the date of event (20-aug-2023) is considered to be a best estimate.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 journal article: "management of massive flank hernia after lateral lumbar fusion: preoperative botulinum toxin injections and open repair ¿ a case report".Incisional flank hernias represent a complication after lateral lumbar spine surgery.Given the increasing rate of lateral lumbar interbody fusions, the rate of incisional flank hernias will increase.Preoperative management involved ct-guided botulinum toxin injections into the lateral abdominal wall muscles to relax and lengthen them, facilitating closure.Definitive treatment was an open flank hernia repair with mesh reinforcement, ensuring optimal myofascial re-approximation and skin closure.Conclusion at the 2-week follow-up, pain was improving, but swelling at the left flank surgical site suggested a postoperative seroma.By the 4-week follow-up, the seroma, pain, and discomfort had completely resolved, though bulging in the left lateral abdominal wall was noted.A ct scan at 2 months showed no evidence of the previous hernia defect.The patient experienced complete resolution of pain and abdominal wall defect, the use of pre-operative botulinum toxin injections prior to massive lateral flank hernia repair is recommended.Note: there is no information provided in the article indicating that the device caused or contributed to the postoperative patient complication(s).However, as postoperative complications did present and may require medical/surgical intervention we are reporting this as a serious injury mdr.

• 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: 23816484
• Report Number: 1213643-2025-01217
• Device Sequence Number: 15790308
• Product Code: FTL
• UDI-Device Identifier: 00801741031625
• UDI-Public: (01)00801741031625
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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 Catalogue Number: 5954460
• 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: 12/01/2025
• Initial Report FDA Received Date: 12/16/2025
• 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 Age: 75 YR
• Patient Sex: Male