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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX L/P SURGICAL MESH Back to Search Results
Catalog Number 0134680
Device Problems Material Too Rigid or Stiff (1544); Defective Device (2588)
Patient Problems Adhesion(s) (1695); Erosion (1750); Hernia (2240)
Event Date 01/27/2009
Event Type  Injury  
Manufacturer Narrative
The cause of the patient's post-op complications cannot be determined at this time. No medical records have been provided. The description alleges mesh became hard; however, no sample has been returned for evaluation. Recurrence and adhesions are known inherent risks of surgery and are listed in the instructions-for-use as possible complications. Based on the limited information provided at this time, no conclusions can be made. This emdr represents the bard/davol composix l/p (device #1). An additional emdr was submitted to represent the bard/davol composix kugel (device #2). Should additional information be provided a supplemental emdr will be submitted. No sample returned.
 
Event Description
The following was alleged by the patient's attorney: on (b)(6) 2007: the patient underwent repair of a ventral incisional hernia. A bard/davol composix l/p (device #1) hernia mesh 6. 2" x 8. 2, reference number 0134680, lot number darh0002 was implanted in patient during this repair. On (b)(6) 2008: the patient underwent surgery to repair the same hernia, in addition to a new hernia. During the surgery, the surgeon found "wall to wall scar tissue" requiring removal, bowel adhesions requiring removal, and the additional of new mesh, including a bard/davol composix kugel (device #2) hernia patch, 5. 4" x 7. 0", reference number 0010202, lot number 43jqd537, on a new hernia. On (b)(6) 2009: the patient underwent surgery to address "severe pain from previous mesh eroding into the abdominal wall". The surgeon noted that "these mesh grafts are rick hard and just eroding themselves through the abdominal wall. " the meshes (device #1 and device #2) were all removed and an alloderm graft was used to close the space. As alleged, the patient continues to experiences complications related to the composix l/p and composix kugel patch. He has already required additional surgeries and may even require further surgeries to repair the damage from the products. As alleged, the patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, impairment.
 
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Brand NameCOMPOSIX L/P
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
Manufacturer Contact
francesca santamaria
100 crossings blvd.
warwick, RI 02886
4018258538
MDR Report Key8137315
MDR Text Key129457856
Report Number1213643-2018-04427
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061754
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/28/2012
Device Catalogue Number0134680
Device Lot NumberDARH0002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/28/2007
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: 12/06/2018 Patient Sequence Number: 1
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