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 Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Hernia (2240); Injury (2348); Disability (2371)
Date of Event	03/27/2014
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.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.This emdr represents the bard/davol perfix light plug (device #1).An additional emdr was submitted to represent the bard/davol ventralex st.(device #2).Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2012: the patient underwent umbilical hernia repair.A perfix plug light (device #1) was implanted in the patient during this repair.(b)(6) 2015: the patient underwent incisional hernia repair.A ventralex st (device #2) was implanted in the patient during this repair.(b)(6) 2014: the patient underwent removal of the failed perfix plug light (device #1).Upon opening the patient the physician noted ¿plug was protruding into the abdomen and small bowel was stuck to it.¿ (b)(6) 2016: the patient underwent removal of the failed ventralex st (device #2).The physician noted ¿lacerated segment of a 2-cm area of bowel that had been torn from it attachment at the edge of the hernia.¿ the mesh implanted in the patient failed to reasonably perform as intended.The mesh caused serious injury and had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the mesh was initially implanted to treat.The patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, 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: 8217659
• Report Number: 1213643-2019-00034
• Device Sequence Number: 1710297
• 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: 2012
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2019

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: 0117060
• Device Lot Number: HUVB0559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/04/2019
• 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