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

Catalog Number	UNKAA107
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994)
Date of Event	06/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made.We are unable to contact the reporter for additional information.No lot number has been provided; therefore, a review of the manufacturing records is not possible.As reported, the patient experienced pain, and migration post implant of the onflex mesh.The adverse reactions section of the instructions for use, supplied with this device lists, pain and migration as possible complications.Note, the date of event and date of implant are considered to be a best estimate as (b)(6) 2019 based on the available information.Should additional information be provided, a supplemental mdr will be submitted.Not returned.
Event or Problem Description
As alleged, the patient was implanted with a bard/davol onflex mesh.It was reported that the surgery took place "two years ago".It is alleged that the patient has had pain since surgery and allegedly an mri shows the mesh has migrated and is damaging other areas of the body.As reported, "the mesh will probably be removed as it seems to be hurting his nerves and one testicle." as reported, the patient's doctor has proposed to re-operate.It is reported that the patient wants to continue in the pain clinic at this time and does not want to undergo re-operation.
Event or Problem Description
As alleged, the patient was implanted with a bard/davol onflex mesh.It was reported that the surgery took place "two years ago".It is alleged that the patient has had pain since surgery and allegedly an mri shows the mesh has migrated and is damaging other areas of the body.As reported, "the mesh will probably be removed as it seems to be hurting his nerves and one testicle." as reported, the patient's doctor has proposed to re-operate.It is reported that the patient wants to continue in the pain clinic at this time and does not want to undergo re-operation.
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made.We are unable to contact the reporter for additional information.No lot number has been provided; therefore, a review of the manufacturing records is not possible.As reported, the patient experienced pain, and migration post implant of the onflex mesh.The adverse reactions section of the instructions for use, supplied with this device lists, pain and migration as possible complications.Note, the date of event and date of implant are considered to be a best estimate as (b)(6) 2019 based on the available information.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to remove the udi number, which was entered inadvertently in the initial mdr.Should additional information be provided, a supplemental mdr will be submitted.

• 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
• MDR Report Key: 12617287
• Report Number: 1213643-2021-20356
• Device Sequence Number: 13790656
• Product Code: FTL
• UDI-Device Identifier: 00801741074424
• UDI-Public: (01)00801741074424
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K142711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: UNKAA107
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention