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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. MESH - COMPOSIX KUGEL SURGICAL MESH Back to Search Results
Catalog Number 0010204
Device Problem Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
This is an addendum to the initial emdr to document additional information provided. As reported the surgeon has not assessed the reported pain as being related to the implanted devices. At this time the patient's treatment is ongoing. Based on the additional information provided, the results of this investigation remain unchanged, at this time we are unable to determine to what extent, if any the bard devices may have caused or contributed to the events as alleged. Should additional information be provided, a supplemental emdr will be submitted. This supplemental emdr represents lot number 43bod272 (device #2) an additional supplemental emdr was submitted representing lot number 43dpd334 (device#1).
 
Event Description
It was reported that approximately ten years ago (no date provided) the patient was implanted with two bard composix kugel hernia patch devices. The patient has recently presented to his physician alleging the devices are causing him "abdominal pain and problems" and wants to have the devices removed. Addendum: on (b)(6) 2005 - the patient was implanted with a bard composix kugel hernia patch (device #1) to treat the hernia defect. On (b)(6) 2006 - the patient underwent an additional surgery in which a bard composix kugel hernia patch (device #2) was placed at the edge of the prior implant to reinforce the area. As reported the implanting surgeon believes the patient may have undergone a primary repair of the defect prior to the implant of the composix kugel hernia patch devices. The allegation of pain is a recent complication and the surgeon has not assessed it to be related to the earlier repairs. The surgeon has refered the patient to a gi specialist for additional consideration of cause of the pain.
 
Manufacturer Narrative
Based on the limited information provided we are unable to determine to what extent, if any the bard devices may have caused or contributed to the events as alleged. To date no additional information has been provided. There have been no other reported complaints for this lot number. Based on the provided lot number the subject product is part of the composix kugel recall, initiated on (b)(6) 2005. Should additional information be provided, a supplemental emdr will be submitted. This emdr represents lot number 43bod272 (device #2) an additional emdr was submitted representing lot number 43dpd334 (device#1). Not returned.
 
Event Description
It was reported that approximately ten years ago (no date provided) the patient was implanted with two bard composix kugel hernia patch devices. The patient has recently presented to his physician alleging the devices are causing him "abdominal pain and problems" and wants to have the devices removed.
 
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Brand NameMESH - COMPOSIX KUGEL
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 sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7155231
MDR Text Key256807201
Report Number1213643-2017-01146
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K003323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 01/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2009
Device Catalogue Number0010204
Device Lot Number43BOD272
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2004
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0761-06

Patient Treatment Data
Date Received: 12/29/2017 Patient Sequence Number: 1
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