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

Catalog Number	0117016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930); Seroma (2069)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the contents of the article, no conclusions can be made.The information provided in the article indicates that some patients experienced post operative complications.The information obtained is limited to the content of the article.The article does not report any specific device malfunction or post-op complications were caused or contributed to the use of the bard soft mesh.The adverse reaction section of the instructions-for-use, supplied with the device identifies seroma, hematoma and infections as possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event (01-apr-2019) 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: "impact of transversus abdominis release (tar) with botulinum toxin (btx) injection versus tar without btx injection on quality of life and postoperative pain in large ventral hernia repair: a comparative study" this prospective cohort study investigated whether adjunctive botulinum toxin (btx) injection improves outcomes in patients undergoing transversus abdominis release (tar) for large ventral hernia repair.The study aimed to assess postoperative pain, intra-abdominal pressure (iap), quality of life, and recurrence rates, with bard soft mesh used for abdominal wall reinforcement.Patients aged 18 years or more with large ventral hernias (defect width 10 cm or more) were included.Btx was administered for defects more than 12 cm, sabbagh's index 20% or more, or mild to moderate pulmonary compromise.Ninety-seven patients were analyzed (april 2019-june 2023): tar+btx group (n-55) and tar-only group (n-42).All repairs utilized bard soft mesh (30x30 cm) placed in the retro muscular plane.Btx injections (200 units botox, allergan) were given four weeks preoperatively.Outcomes were assessed over 12 months using herqles scores, iap measurements, pain scores, and recurrence monitoring.Mesh-related complications were minimal.Surgical site occurrences (sso) such as seroma, hematoma, and wound infection occurred in 12.7% of tar+btx and 11.9% of tar-only cases, all managed conservatively except one requiring debridement.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 some requiring medical/surgical intervention we are reporting this as a serious injury mdr.

• Brand Name: BARD SOFT 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: 24018814
• Report Number: 1213643-2025-01331
• Device Sequence Number: 10555151
• Product Code: FTL
• UDI-Device Identifier: 00801741030932
• UDI-Public: (01)00801741030932
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: 0117016
• 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: 12/19/2025
• Initial Report FDA Received Date: 01/09/2026
• 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: Other
• Patient Sex: Unknown