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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. PERFIX PLUG SURGICAL MESH Back to Search Results
Catalog Number UNKAA053
Device Problems Defective Device (2588); Extrusion (2934)
Patient Problems Adhesion(s) (1695); Hernia (2240); Disability (2371)
Event Date 04/10/2017
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event. To date no medical records have been provided. Without a lot number a review of the manufacturing records could not be conducted. It is alleged the patient experienced extrusion of mesh as well as adhesions and hernia recurrence. Recurrence, adhesions and extrusion are all listed as known possible adverse reaction in the instructions-for-use. With the currently available information, no definitive conclusion can be drawn. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. This file represents the left perfix plug mesh implanted in (b)(6) 2012. Additional files have been created to address the right sided perfix plug and the 3dmax mesh implanted on (b)(6) 2016. 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 to manufacturer.
 
Event Description
The following was reported to davol by the patient's attorney: on (b)(6) 2012 - the patient underwent emergency surgery to repair bilateral incarcerated inguinal hernias. The patient was implanted with two perfix plugs-one on the left and one on the right. A few weeks after his surgery, it is alleged the patient began to experience significant pain in his groin, abdomen and testicles, which the patient described as "burning", "ripping", and "pulling" sensations. Additionally, he experienced abdominal bloating, bowel issues and frequent vomiting. On (b)(6) 2012-(b)(6) 2016 - the patient's pain and discomfort increased in severity and the patient sought medical attention and underwent various medical imaging tests to assess his condition. He was advised by his doctor that the imaging tests demonstrated scarring and inflammation, which imposed difficulties visualizing the mesh. On (b)(6) 2016 - the patient returned to see the doctor to assess his chronic pain. Patient was advised that on physical assessment there was a bulge on the left side because his hernia had recurred. He was referred to a specialist for a second opinion. On (b)(6) 2016 - the patient was assessed by a second doctor who advised him that he was experiencing pain as a result of the scarring and inflammation around his nerves and spermatic cord. Patient was also advised that his left side had re-herniated, and that he required surgery to repair the recurrent hernia. On (b)(6) 2016 - the patient underwent a laparoscopic repair of his left recurrent inguinal hernia using a 3d max mesh. His operative report indicates that significant adhesions were noted from his first hernia surgery. Post procedure the patient continued to experience severe groin pain and frequent vomiting. In weeks following surgery, the patient described feeling a "ripping" sensation from his left groin to the center of his abdomen. Concerned that his hernia had recurred, patient sought medical attention. Medical imaging revealed his left hernia had recurred. On (b)(6) 2017 - the patient underwent a third surgery to repair his recurrent left inguinal hernia. His operative report indicates that his surgeon "noted the old hernia plug had extruded to be firmly adherent to the spermatic cord. " the perfix plug was explanted , while attempting to preserve the left testicle. The attorney alleges the patient continues to suffer from chronic nerve pain, pelvic pain, nausea and vomiting. It is further alleged that the patient's symptoms interfere with his employment abilities; patient has been unable to work since (b)(6) 2013. The patient is unable to assist with many of his day to day tasks.
 
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Brand NamePERFIX PLUG
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
BARD SHANNON LIMITED -3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key6741054
MDR Text Key80947718
Report Number1213643-2017-00436
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K922916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial
Report Date 07/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA053
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/25/2017 Patient Sequence Number: 1
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