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

Catalog Number	0117060
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976)
Health Effect - Clinical Codes	Hernia (2240); Injury (2348); Disability (2371)
Date of Event	02/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol perfix light plug device may have caused or contributed to the reported event.To date no medical records have been provided.The attorney alleges the patient underwent an additional surgery for recurrent hernia and to remove the device.The device was explanted and was found to be thickened, flattened and contracted.Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Based on the limited information provided at this time, no conclusions can be made.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) 2015: the patient underwent right inguinal hernia repair.A perfix light plug was implanted in patient during this repair.On (b)(6) 2018: the patient underwent a recurrent hernia operation due to right groin pain.The physician noted, ¿palpation demonstrated an additional foreign body consistent with a potential plug of mesh.It was thickened, flattened, contracted.¿ ni/ni/ni: the patient continues to suffer complications related to the perfix light plug.The perfix light plug implanted in patient failed to reasonably perform as intended.The perfix light plug caused serious injury and had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the perfix light plug was initially implanted to treat.The patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, 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: 7962577
• Report Number: 1213643-2018-03540
• Device Sequence Number: 10813488
• Product Code: FTL
• UDI-Device Identifier: 00801741030956
• UDI-Public: (01)00801741030956
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2018

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: 02/28/2020
• Device Catalogue Number: 0117060
• Device Lot Number: HUZC0195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/12/2018
• 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