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

Catalog Number	0117170
Medical Device Problem Codes	Material Erosion (1214); Defective Device (2588)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Disability (2371)
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 #1) device may have caused or contributed to the reported event.To date no medical records have been provided.The attorney alleges the patient had to undergo various revision surgeries and medical procedures including, but not limited to various surgical procedures in an attempt to remove the eroded mesh.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.This emdr represents the bard/davol perfix light plug (device #1).An additional emdr was submitted to represent the bard/davol perfix light plug (device #2).Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2012: the patient underwent surgery for repair of a right inguinal hernia.The bard/davol perfix light plug (device #1) was implanted to repair the hernia defect.Ni/ni/ni: the patient has had to undergo various revision surgeries and medical procedures including, but not limited to various surgical procedures in an attempt to remove the eroded mesh.On (b)(6) 2013: the patient underwent an additional surgery to repair a right femoral hernia and umbilical hernia.The bard/davol perfix light plug (device #2) was implanted to repair the hernia defect.Patient was injured severely and permanently.Patient has suffered and continues to suffer from chronic debilitating pain, as well as significant psychological stress and depression.The patient has undergone and will likely require in the further other forms of care and medical treatments.

• 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: 7967088
• Report Number: 1213643-2018-03552
• Device Sequence Number: 1394850
• Product Code: FTL
• UDI-Device Identifier: 00801741031007
• UDI-Public: (01)00801741031007
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2018

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: 05/28/2017
• Device Catalogue Number: 0117170
• Device Lot Number: HUWE0298
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/15/2018
• 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