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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 UNKAA016
Device Problems Defective Device (2588); Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Injury (2348); Disability (2371); Insufficient Information (4580)
Event Date 08/31/2011
Event Type  Injury  
Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.
 
Event Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol kugel hernia patch.As reported, the patient is making a claim for an adverse patient outcome against kugel hernia patch (date of implant not provided).Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is alleged that the patient sustained injuries on (b)(6) 2011 and (b)(6) 2019.It is also alleged that the patient experienced emotional distress and the device was defective.
 
Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this is an addendum to the initial emdr submitted.This supplemental emdr is submitted to report the corrected product name, date of implant and date of event provided in the legal claim.Updated fields: b4, b5, d6a (date of implant), g3, g6, h2, h6, h10, h11.Corrected fields: b3 (date of event), d1 (brand name), d4 (product catalog no.), g4 (pma/510(k) #).Should additional information be provided, a supplemental emdr will be submitted.Note: section a through f - the information provided by bd 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 bd.H3 other text : not returned.
 
Event Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol kugel hernia patch.As reported, the patient is making a claim for an adverse patient outcome against kugel hernia patch (date of implant not provided).Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is alleged that the patient sustained injuries on (b)(6)2011 and (b)(6) 2019.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per legal claim: attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix kugel hernia patch and ventrio st on (b)(6) 2011 and/or (b)(6) 2019.As reported, the patient is making a claim for an adverse patient outcome against composix kugel hernia patch.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is alleged that the patient sustained injuries on (b)(6) 2011.It is also alleged that the patient experienced emotional distress and the device was defective.(note, the date of implant of the composix kugel hernia patch is considered as (b)(6) 2011 since it was not available in 2019.).
 
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Brand Name
MESH COMPOSIX KUGEL
Type of Device
SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
MDR Report Key11287016
MDR Text Key230533114
Report Number1213643-2021-00840
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K061314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKAA016
Was Device Available for Evaluation? No
Date Manufacturer Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Disability;
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