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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 E/X SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX MESH E/X SURGICAL MESH Back to Search Results
Model Number 0123810
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Pain (1994); Hernia (2240); Disability (2371)
Event Date 06/23/2010
Event Type  Injury  
Manufacturer Narrative
Addendum to the previous report. This supplemental emdr is being sent to indicate that there was no explant of the composix mesh ex device as previously reported. It is unknown if the device was explanted during the second procedure.
 
Event Description
It is alleged by the patients attorney that on (b)(6) 2007, the patient underwent surgery for repair of an incisional hernia. As reported, a bard/davol composix e/x hernia patch mesh, reference number (b)(4), lot number 43aqd352 was implanted to repair the hernia defect. It is alleged that several years later on (b)(6) 2010, the patient underwent an additional surgery for a recurrent hernia. As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective composix e/x hernia patch.
 
Manufacturer Narrative
To date, limited information has been provided. Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged. Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication. Review of the device history records found lot was manufactured to specification. No anomalies identified. If additional information is obtained, a supplemental mdr will be submitted. 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
It is alleged by the patients attorney that on (b)(6) 2007, the patient underwent surgery for repair of an incisional hernia. As reported, a bard/davol composix e/x hernia patch mesh, reference number (b)(4), lot number 43aqd352 was implanted to repair the hernia defect. It is alleged that several years later on (b)(6) 2010, the patient underwent an additional surgery for a recurrent hernia. As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective composix e/x hernia patch.
 
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Brand NameCOMPOSIX MESH E/X
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
MDR Report Key7142549
MDR Text Key291323464
Report Number1213643-2017-01098
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K002684
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 08/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/28/2011
Device Model Number0123810
Device Catalogue Number0123810
Device Lot Number43AQD352
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received07/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/22/2017 Patient Sequence Number: 1
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