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

Catalog Number	0115814
Medical Device Problem Codes	Defective Device (2588); No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Disability (2371); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported unspecified post-operative complications and any problem with the bard/davol device used to treat the patient.The patient's attorney did not allege a specific device failure or patient adverse event, and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.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/davol kugel patch implanted on (b)(6) 2013 (device 1).An additional emdr will be submitted to represent the bard/davol ventralex implanted on (b)(6) 2013 (device 2).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 or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2013 - the patient underwent surgery for implant of an unspecified bard/davol kugel hernia patch (device 1) and an unspecified bard/davol ventralex (device 2).As reported, the patient's attorney alleges a general claim "for past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained".
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2013 - the patient underwent surgery for implant of an unspecified bard/davol kugel hernia patch (device 1) and an unspecified bard/davol ventralex (device 2).As reported, the patient's attorney alleges a general claim "for past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained".Addendum per additional information provided: (b)(6) 2013 - patient was diagnosed with left inguinal hernia and umbilical hernia thereby underwent open hernia repair with the implant of modified kugel patch (device #1) and ventralex mesh (device #2).Per operative notes, "the cord was isolated, a direct hernia was noted.The patch is lubricated with saline and placed extra peritoneally covering the direct, indirect and femoral spaces.External oblique aponeurosis is apposed overlying the kugel mesh (device #1).The hernia sac is excised from the underside of umbilical skin.The ventralex mesh (device #2) was lubricated with saline, placed intrafascially and attached to the fascia and sutured." (b)(6) 2016 - patient was diagnosed with recurrent infected ventral hernia thereby underwent open hernia repair with the removal of ventralex mesh (device #2).Per operative notes, "a hard indurated mass below the skin of the umbilicus was noted and dissected and found to have cavity containing pus.The abscess cavity was opened and found near to the anterior side of mesh.The ventralex mesh (device #2) was removed entirely.The indurated area with abscess was removed.The ventral hernia repair was done with sutures." (note: there was no visualization/mention of modified kugel patch (device #1)) attorney alleges that the patient had abscess, infection, pain, hernia recurrence; loss of umbilicus and emotional injuries.
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported unspecified post-operative complications and any problem with the bard/davol device used to treat the patient.The patient's attorney did not allege a specific device failure or patient adverse event, and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Addendum: this supplemental emdr is submitted to document additional information provided.Upon review of medical records, it was confirmed there was no adverse event or medical/surgical intervention associated to the modified kugel patch implanted to treat the patient's recurrent hernia.Note, the manufacturing date (15-may-2012) is considered to be a best estimate.Updated fields: a2, a4, b4, b5, b6, b7, d1 (brand name), d4 (product catalog no, corporate lot no, expiry date, udi no), e3, g1, g2 (reports source - other), g3, g6, h2, h4, h6, h10.This supplemental emdr is submitted to represents modified kugel patch (device #1).Additional supplemental emdr was submitted to represent mesh ¿ ventralex (device #2).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.

• Brand Name: MODIFIED KUGEL PATCH
• Common Device Name: SURGICAL 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 Key: 7363247
• Report Number: 1213643-2018-00725
• Device Sequence Number: 10789613
• Product Code: FTL
• UDI-Device Identifier: 00801741030819
• UDI-Public: (01)00801741030819(17)170828(10)HUWE0980
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2017
• Device Catalogue Number: 0115814
• Device Lot Number: HUWE0980
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Male
• Patient Weight: 87 KG