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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX MESH SURGICAL MESH Back to Search Results
Catalog Number 0113810
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Disability (2371); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol composix kugel may have caused or contributed to the reported event. To date no medical records have been provided. The attorney alleges the patient underwent an additional surgery to treat a "reccurrent" hernia. Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication. In addition the patient has an open wound and infection. Regarding infection the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. ¿ a review of the manufacturing records was performed as well as a sterilization process review and found that the lot was manufactured to specification. No sample has been returned for evaluation. 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 composix mesh (device #2). An additional emdr was submitted to represent the bard/davol composix kugel (device #1). Note: not returned.

 
Event Description

The following was alleged by the patient's attorney: on (b)(6) 2010:the patient underwent repair of an incarcerated incisional hernia. The patient was implanted with a bard/davol bard composix kugel (device #1). The patient suffered from chronic pain in her lower abdomen, constipation, an open wound that had trouble healing, and a recurrent hernia. On (b)(6) 2012: the patient underwent repair of a recurrent incisional hernia. It is alleged that the patient was implanted with a bard/davol composix mesh (device #2). The patient began to suffer chronic pain in her lower abdomen and constipation. The patient had an open wound that had trouble healing, and she required wound vac care to treat the incision. It is alleged that the patient has suffered from the open wound since 2012 and has had to continually treat seepages with bandages. The patient has also had to deal with infections related to the incision. The patient continues to experience these complications related to the bard/davol hernia mesh and will continue to suffer from them in the future. The patient's hernia mesh complications cause her pain and suffering, and physical impairment. It is alleged that the polypropylene surgical mesh bard/davol composix kugel (device #1) / bard/davol composix mesh ( device #2)) is defective. The patient has suffered and will continue to suffer permanent pain and suffering and disfigurement. It is alleged that the patient has suffered, sustained and incurred, and in reasonable medical probability will continue to suffer, sustain and incur the following injuries and damages, among others: physical pain, mental anguish, disfigurement, physical impairment, and medical care and treatment.

 
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Brand NameCOMPOSIX MESH
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
jan ling
100 crossings blvd.
warwick, RI 02886
8015652663
MDR Report Key8006613
MDR Text Key125045351
Report Number1213643-2018-03718
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK971745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 10/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2012
Device Catalogue Number0113810
Device LOT NumberHURG0388
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/29/2007
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: 10/25/2018 Patient Sequence Number: 1
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