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

Catalog Number	0115410
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Reaction (2414)
Date of Event	01/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported postoperative complications and any problem with the davol device used to treat the patient.As reported the patients doctor is continuing to treat the patient.At this time no conclusion can be made as to the cause of the patient complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification, with no anomalies noted.Should additional information be obtained, a supplemental emdr will be submitted.The information provided by bard 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 bard.Remains implanted.
Event or Problem Description
The following was reported to davol: (b)(6) 2018 - the patient was implanted with a davol onflex mesh.As reported since implant the patient had complained of severe pain.(b)(6) 2018 - due to pain the patient underwent an additional surgery.As reported no abnormalities were found.Following the additional surgery it is reported that the patient was free of symptoms for approximately six weeks, but has started to experience increasing pain and has been unable to work.The patient's doctor reports that the patient experienced a "rejection reaction" which manifests itself by the following symptoms: severe pelvic pain, increased crp (c-reactive protein), leukocytosis, no abscess, no seroma.The patient continues to have complaints of malaise and local pain without signs of bacterial inflammation.Ct scan performed on (b)(6) excludes an abscess, but the perifocal muscles are swollen without involvement of intra-abdominal organs.

• Brand Name: ONFLEX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7420846
• Report Number: 1213643-2018-01021
• Device Sequence Number: 70382
• Product Code: FTL
• UDI-Device Identifier: 00801741074424
• UDI-Public: (01)00801741074424
• Combination Product (Y/N): N
• PMA/510(K) Number: K142711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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: 06/28/2020
• Device Catalogue Number: 0115410
• Device Lot Number: HUBS0682
• Was Device Available for Evaluation?: No
• Event Location: Ambulatory Surgical Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/11/2018
• 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