Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PERFIX LIGHT PLUG; SURGICAL MESH
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DAVOL INC., SUB. C.R. BARD, INC. PERFIX LIGHT PLUG; SURGICAL MESH Back to Search Results
Catalog Number 0117070
Medical Device Problem Codes Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Hernia (2240); Injury (2348); Disability (2371)
Date of Event 11/17/2015
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 #2) device may have caused or contributed to the reported event.The attorney alleges the patient underwent an additional surgery to remove the device and testicle.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 #2).An additional emdr was submitted to represent the bard/davol perfix light plug (device #1).Note: not returned.
 
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2015: the patient underwent bilateral inguinal hernia repair.A bard/davol perfix light plug (device #1 and device #2) was implanted in the patient during this repair.On (b)(6) 2015: the patient underwent removal of the failed perfix light plug (device #1 and device #2) and patient's testicle.The patient continues to suffer complications related to the mesh.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8125894
Report Number1213643-2018-04308
Device Sequence Number1630792
Product Code FTL
UDI-Device Identifier00801741030963
UDI-Public(01)00801741030963
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
K092032
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2015
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/03/2018
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 Catalogue Number0117070
Device Lot NumberHUYK1365
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/11/2018
Initial Report FDA Received Date12/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention; Disability;
-
-