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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 0112780
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Hernia (2240); Disability (2371); Post Operative Wound Infection (2446)
Event Date 11/11/2003
Event Type  Injury  
Manufacturer Narrative

No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, wound infection, pain and surgical intervention; however, no details have been provided. The instructions-for-use supplied with the device lists hernia recurrence as a possible complication. A review of the manufacturing records was performed and found that the lot was manufactured to specification. In regards to the infection, the warning section of the ifu states: "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device. " this emdr represents the bard/davol perfix plug (device #1). An additional emdr was submitted to represent the bard/davol composix mesh e/x (device #2). Should additional information be provided, a supplemental emdr will be submitted.

 
Event Description

Attorney alleges that the patient underwent surgery for repair of a left indirect inguinal hernia on or about (b)(6) 2003. A bard/davol perfix plug was implanted to repair the hernia defect. On or about (b)(6) 2003, the patient underwent an additional surgery to repair the recurrent left inguinal hernia. It is alleged that the patient underwent additional surgery involving an exploration of wound sinus, resection of infected mesh and suture repair of hernia on or about (b)(6) 2004. On or about (b)(6) 2005, the patient underwent surgery for repair of an incisional hernia and a bard/davol composix e/x was implanted to repair the hernia defect. Attorney alleges that the patient underwent a removal of abdominal wall mesh after presenting with a sinus draining and sepsis on or about (b)(6) 2006. On or about (b)(6) 2007, the patient underwent additional surgery to repair an incisional hernia. It is alleged that the patient was injured severely and permanently. The patient suffered pain, disability, hospitalizations and additional surgeries. It is also alleged that the patient has suffered and will continue to suffer physical pain, chronic pain, mental anguish, psychological stress, depression, has undergone and will likely require medical treatments and other forms of care. Attorney also alleges that the device was defective.

 
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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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key10721930
MDR Text Key212717267
Report Number1213643-2020-09609
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK922916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 10/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2008
Device Catalogue Number0112780
Device LOT Number43DND314
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/21/2003
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: 10/22/2020 Patient Sequence Number: 1
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