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

Catalog Number	0115410
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Hernia (2240); Post Operative Wound Infection (2446)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per journal article in hernia (2021) titled, ¿safety and efficacy in inguinal hernia repair: a retrospective study comparing trepp, tep and lichtenstein (settle).¿ featured was a retrospective cohort study, 300 patients of which 58 (19.3%) underwent trepp, 190 (63.3%) tep and 52 (17.3%) lichtenstein with bard/davol onflex, non-bard/davol parietex, non-bard/davol biomesh respectively over a period of 7 months from march to september 2019.The primary outcome of this study was inguinal hernia recurrence rate within 1 year after surgery.Secondary objectives were chronic post-operative inguinal pain (cpip) lasting more than 6 months, (major) complication rates and operating time.The following complications were observed from 58 patients treated with onflex mesh during trepp inguinal hernia repair: recurrence 2 (1.7%) patients; chronic pain (>6 months) 1 (1.7%) patient; hematoma (surgical evacuation) 5 (8.6%) patients & wound infection 4 (6.9%) patients.Information is presented without patient/case specific details.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.The information obtained is limited to the article.As reported, post-implant of the onflex mesh, patients developed hernia recurrence, wound infection, chronic pain & hematoma.Hematoma, pain, infection, and recurrence of the hernia are known inherent risks of surgery/use of the device and are listed in the adverse reactions section of the instructions-for-use, supplied with the device, as possible complications.Regarding infection the ifu 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 mesh." no lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event is provided as an estimate based on the information provided.Not returned.

• 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: 15978190
• Report Number: 1213643-2022-00792
• Device Sequence Number: 12208636
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2022

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): Initial
• Initial Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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