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

Catalog Number	0115410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information available, no conclusions can be made.The information obtained is limited to the content of the article.The article does not report that any specific device malfunction or alleged post-op complications were caused or contributed to the use of the onflex mesh.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Infection, hernia recurrence, hematoma, seroma and pain are listed in the adverse reactions section of the instructions-for-use supplied with the device as possible complications.Regarding infection the warning section states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device".Note, the date of event (01-jan-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: "trans rectus sheath extra-peritoneal procedure (trepp) for inguinal hernia repair under local anesthesia with sedation in the outpatient clinic: a feasibility study." the article describes retrospective feasibility study which investigates the safety and efficiency of trepp under local anesthesia in the outpatient clinic in comparison with lichtenstein between 2019 and 2022.It was performed examining 247 patients (34 patients in the trepp group and 213 patients in the lichtenstein group) who underwent an elective inguinal hernia repair under local anesthesia in the outpatient clinic operation theatre.The following complications was observed during inguinal hernia repair for trepp group patients treated with onflex mesh had inguinal hernia recurrence within 8 weeks occurred 1 time in the trepp group.A sub-analysis on 6-months recurrence rate showed 2 hernia recurrences in the trepp group, this includes the recurrence within 8 weeks in both groups.Pain was present after 8 weeks post-operatively in (n=3) 8.8% of the patients in the trepp group.Wound infection, trepp, n=1(2.9%); hematoma, trepp, n=5(14.7%); seroma, trepp n=1(2.9%).The article concluded that trepp under sedation and local anesthesia in the outpatient clinical setting is feasible and safe in terms of intra-operative and early post-operative outcomes.The intra-operative and post-operative complication rates were overall low and were comparable with the lichtenstein technique.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: ONFLEX
• 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: 22510949
• Report Number: 1213643-2025-00638
• Device Sequence Number: 15616451
• Product Code: FTL
• UDI-Device Identifier: 00801741074424
• UDI-Public: (01)00801741074424
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K142711
• 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): 06/27/2025

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: 0115410
• 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: 06/25/2025
• Initial Report FDA Received Date: 07/15/2025
• 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