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

Catalog Number	0117080
Medical Device Problem Codes	Defective Device (2588); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Disability (2371)
Date of Event	08/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time it is unknown to what extent the device may have caused or contributed to the reported event.The information provided alleges that the patient underwent an additional surgery to explant the device and the device was protruding, however, no medical records were not provided and no clarification regarding the alleged protrusion has been provided.A review of the manufacturing records was conducted.Product was manufactured to specification with no anomalies.Information is limited at this time.Should additional information be provided 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.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2016, the patient underwent left inguinal hernia repair.It is alleged that a large bard/davol perfix light plug, cat.No.0117080 lot no.Huzk0222 was implanted in the patient during this repair.On (b)(6) 2016, the underwent removal of the failed perfix light plug.The surgeon noted that he was ¿concerned that this was the mesh protruding backwards and causing her a great deal of pain.¿ it is alleged that during the surgery, the surgeon noted that ¿there was a very firm mass in the area of concern this was consistent with the previous mesh.¿ the patient continues to suffer complications from the bard/davol perfix light plug.It is alleged that the bard/davol perfix light plug is defective.The patient has been injured and sustained severe pain, suffering, disability, and impairment.

• Brand Name: PERFIX LIGHT PLUG
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7877128
• Report Number: 1213643-2018-03125
• Device Sequence Number: 16656621
• Product Code: FTL
• UDI-Device Identifier: 00801741030970
• UDI-Public: (01)00801741030970
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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: 10/28/2020
• Device Catalogue Number: 0117080
• Device Lot Number: HUZK0222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/14/2018
• 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; Disability