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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 0112960
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Neuropathy (1983); Pain (1994); Disability (2371)
Event Date 06/15/2012
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. The patient's attorney did not allege any specific device failure and a sample was not returned for further evaluation. Based on the limited information provided by the patient's attorney, no conclusions can be made between the bard/davol device used to treat the patient and any problem with the device. Should additional information be provided, a supplemental emdr will be submitted. Note: the actual date of removal surgery is unknown, as reported by the patient's attorney the patient "underwent surgery in 2012" the patients "surgeon removed part of the mesh. " therefore we are using (b)(6) 2012 as a date of explant. 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 Description
The following was alleged by the patient's attorney: on (b)(6) 2010- the patient was implanted with a bard/davol perfix mesh for the repair of a left inguinal hernia. As reported, "no less than a year had passed before the patient started experiencing pain radiating from his abdomen and neuropathy. Thereafter, the patient's physicians elected for a repair of surgery of the hernia and hernia mesh. " ni/ni/2012- the patient underwent surgery. Upon entering the abdominal cavity, the patient's surgeon noted that the bard perfix mesh had failed and removed part of the mesh. As alleged by the patient's attorney, the patient "has experienced significant physical injury, physical pain and suffering, permanent injury, and has undergone medical treatment and will likely undergo further medical treatment and procedures. " the attorney further alleged that the patient's mesh "failed while in his body causing the patient to develop serious physical complications which required subsequent, painful and unnecessary repair surgery. ".
 
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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
laura abrams
100 crossings blvd.
warwick, RI 02886
4018258605
MDR Report Key7610402
MDR Text Key111361962
Report Number1213643-2018-02011
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
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 06/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/28/2015
Device Catalogue Number0112960
Device Lot NumberHUUD1517
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 Received06/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2010
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: 06/18/2018 Patient Sequence Number: 1
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