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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. KUGEL PATCH SURGICAL MESH Back to Search Results
Catalog Number UNKAA043
Device Problems Defective Device (2588); Extrusion (2934)
Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Disability (2371)
Event Date 01/07/2016
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, we are unable to determine to what extent, if any the bard kugel patch (device #2) may have caused or contributed to the events as alleged by the patient¿s attorney. The information provided alleges the patient "was found to have infected and extruding mesh". The sample was not returned for evaluation and medical records are not available at this time. Adhesions are a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication. Regarding infection the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. ¿ no lot number has been provided; therefore a review of the manufacturing records is not possible at this time. Should additional information be provided a supplemental emdr will be submitted. This emdr represents the bard device implanted on (b)(6) 2013 (device #2). An additional emdr was submitted to represent the bard device implanted on (b)(6) 2007 (device #1). 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. Device not returned.
 
Event Description
The following was alleged by the patient's attorney: (b)(6) 2007: the patient underwent a ventral hernia repair with mesh that, "upon information and belief, was manufactured by bard. " (device #1). (b)(6) 2013: the patient underwent an incisional surgery for a recurrent ventral hernia. The patient's hernia was repair with a bard/davol large oval kugel patch (device #2). (b)(6) 2016: the patient presented to the doctor with complaints of severe pain and extrusion of mesh. As reported, he was found to have infected and extruding mesh. (b)(6) 2016: the patient underwent surgery on the infected mesh. As reported, an exploratory laparotomy, lysis of adhesions, small bowel resection with primary anastomosis, and debridement of his abdominal wall soft tissue were performed and he was sent to the recovery room in stable condition. As alleged, the patient was seriously and permanently injured and has suffered and will continue to suffer physical pain due to the alleged defective kugel patch.
 
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Brand NameKUGEL PATCH
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 Key7221462
MDR Text Key98348173
Report Number1213643-2018-00133
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963141
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial
Report Date 01/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA043
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 Received12/30/2017
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

Patient Treatment Data
Date Received: 01/26/2018 Patient Sequence Number: 1
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