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

Catalog Number	0115410
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Nerve Damage (1979); Injury (2348)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol onflex (device #2).An additional emdr was submitted to represent the bard flat mesh (device #1).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard mesh (bard flat mesh) and bard onflex mesh medium on (b)(6) 2016.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-jun-2015) is considered to be a best estimate.This supplemental emdr represents onflex (device #2).An additional supplemental emdr was submitted to represent bard flat mesh (device #1).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
Attorney alleges that the patient underwent surgery for implant of unspecified bard mesh (bard flat mesh) and bard onflex mesh medium on (b)(6) 2016.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2016 - patient was diagnosed with right inguinal hernia thereby underwent open repair with the implant of onflex (device #2).Per op notes, "no direct hernia defect was identified.The internal inguinal ring was slightly enlarged.The inguinal canal floor was reconstructed with onflex (device #2).Note, there was no mention of bard flat mesh (device #1) being implanted in this procedure.(note: there was no indication in the medical records provided that the patient was implanted with a bard flat mesh.) (b)(6) 2020 - patient was diagnosed with chronic pain, right inguinal neuralgia with meshoma, nerve entrapment thereby underwent with removal of partial mesh (device #1).Per op notes, "there was old mesh in the right inguinal space.Significant amount of adhesions around the mesh were noted.The mesh (device #2) was removed.

• 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 ; 4018258495
• MDR Report Key: 10779601
• Report Number: 1213643-2020-09929
• Device Sequence Number: 19799568
• Product Code: FTL
• UDI-Device Identifier: 00801741074424
• UDI-Public: (01)00801741074424(17)180628(10)HUZF0011
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K142711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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 Expiration Date: 06/28/2018
• Device Catalogue Number: 0115410
• Device Lot Number: HUZF0011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2015
• 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: Disability; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 105 KG