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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); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Unspecified Infection (1930); Obstruction/Occlusion (2422)
Event Date 08/06/2020
Event Type  Injury  
Manufacturer Narrative

No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, infection, disfigurement, blockage and subsequent surgical intervention for mesh removal. The instructions-for-use supplied with the device lists infection as a possible complication. In regards to the infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. Unresolved infection may require removal of the mesh. " note, as specific implant date was not provided, the date of implant was estimated as (b)(6) 2007. Should additional information be provided, a supplemental emdr will be submitted. Not returned.

 
Event Description

Attorney alleges that approximately in 2007, the patient was implanted with a bard/davol kugel hernia mesh. It is alleged that the patient was admitted to the hospital due to abdominal pain on (b)(6) 2020. On (b)(6) 2020, the patient underwent an additional surgery for the removal of kugel hernia mesh along with portions of patient's small intestine due to blockage and infection caused by the kugel hernia mesh. It is also alleged that the patient was discharged from the hospital on (b)(6) 2020 and has continued to receive treatment and surgeries caused by the kugel hernia mesh. Attorney alleges that the patient sustained permanent partial impairment, past and future pain and suffering, mental anguish, scars, disfigurement and injury. It is also alleged that the device was defective.

 
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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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key11765505
MDR Text Key248789937
Report Number1213643-2021-03215
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
Type of Report Initial
Report Date 05/03/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/03/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA043
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2021
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: 05/03/2021 Patient Sequence Number: 1
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