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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 Problems Defective Device (2588); Material Deformation (2976)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Disability (2371)
Event Type  Injury  
Manufacturer Narrative

There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient. The sample was not returned for evaluation. Based on the limited information provided at this time, no conclusions can be made. Inflammation is identified in the adverse reaction section of the instructions-for-use as a possible complication. No lot number was provided therefore a review of the manufacturing records is not possible at this time. Based on the date of implant the subject product is part of the composix kugel recall initiated on (b)(4) 2005. Should additional information be provided a supplemental emdr 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

The following was alleged by the patient's attorney:on (b)(6) 2006: the patient underwent a hernia surgery for a ventral hernia and umbilical hernia. As reported, the patient's hernia was repaired with a bard/davol 11. 4cm x 11. 4cm oval kugel patch, product code 0010204. It is alleged that sometime after placement the device malfunctioned by, inter alia, contracting, suffering degradation, and causing an intense foreign body and inflammatory response. It is alleged that as a result of these failures, the patient has suffered severe injuries, required substantial medical care, has suffered and will continue to suffer physical pain.

 
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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
francesca santamaria
100 crossings blvd.
warwick, RI 02886
4018258538
MDR Report Key7155276
MDR Text Key96109976
Report Number1213643-2017-01148
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK003323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation ATTORNEY
Remedial Action Recall
Type of Report Initial
Report Date 12/29/2017
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 HEALTH PROFESSIONAL
Device Catalogue Number0010204
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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