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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. MODIFIED KUGEL SURGICAL MESH Back to Search Results
Model Number 0115810
Device Problems Hole In Material (1293); Defective Device (2588); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Pain (1994); Disability (2371)
Event Date 09/28/2015
Event Type  Injury  
Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. To date no medical records have been provided. The information provided indicates the patient experienced pain, swelling, abscess and adhesions. In regards to adhesions, adhesions are listed as a known possible adverse reaction in the instructions-for-use. The information also indicated that the mesh had a "hole" in it. A sample was not returned for evaluation therefore the allegation of a "hole" in the mesh can not be confirmed. The modified kugel is designed in such a way that there is an opening in the dual mesh. It is unclear if this designed opening is what is being referred to when talking about the hole in the mesh. With the current information available, no definitive conclusion can be made. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. Not returned to manufacturer.

 
Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2006 - the patient underwent an open abdominal surgery for a ventral incisional hernia. The patient's hernia was repaired with a four inch modified kugel patch. On (b)(6) 2006 - the patient presented to the er with complaints of pain, swelling and redness of lower abdomen. The patient was allegedly found to have "an abscess. " the patient underwent an incision and drainage of the abscess in her lower abdominal wall. On (b)(6) 2015 - the patient underwent surgery to have laparoscopic repair of an incarcerated ventral hernia. The attending surgeon stated "severe adherence of bladder to old mesh and had a hole in it. " the patient was sent to recovery and discharged two days later. The attorney alleges the patient experienced adhesions, swelling, abscess and was seriously and permanently injured.

 
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Brand NameMODIFIED 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
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key6942336
MDR Text Key89245209
Report Number1213643-2017-00667
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK963141
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup
Report Date 02/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/11/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/28/2011
Device MODEL Number0115810
Device Catalogue Number0115810
Device LOT Number43AQD821
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 Received02/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/15/2006
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: 10/11/2017 Patient Sequence Number: 1
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