MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 MODIFIED KUGEL PATCH; SURGICAL MESH

Catalog Number	0115814
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	06/13/2018
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 modified kugel patch 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.Note: 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) 2011: the patient underwent surgery for implant of an unspecified bard /davol modified kugel hernia patch.The patient is making a claim for an adverse patient outcome against the bard/davol modified kugel hernia patch.The 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.".
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 modified kugel patch 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.Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-sep-2011) is considered to be a best estimate.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.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2011: the patient underwent surgery for implant of an unspecified bard /davol modified kugel hernia patch.The patient is making a claim for an adverse patient outcome against the bard/davol modified kugel hernia patch.The 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." addendum per additional information provided: (b)(6) 2011 - patient was diagnosed with symptomatic right inguinal hernia thereby underwent open repair with implant of modified kugel hernia patch.Per operative notes, ¿ a right direct inguinal hernia was noted and reduced circumferentially and modified kugel hernia patch was placed covering both direct and indirect spaces and sutured.¿ (b)(6) 2018 - patient was diagnosed with recurrent incarcerated right inguinal hernia and pain thereby underwent robotic assisted repair with removal of prior mesh and implant of synthetic mesh.Per operative notes, ¿ the direct recurrent right inguinal defect was noted.The sac was dissected and previously placed mesh was removed.The synthetic mesh was placed covering the defects and fascia was closed using sutures.¿.

• Brand Name: MODIFIED KUGEL PATCH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: 7781402
• Report Number: 1213643-2018-02733
• Device Sequence Number: 1011547
• Product Code: FTL
• UDI-Device Identifier: 00801741030819
• UDI-Public: (01)00801741030819(17)160928(10)HUVI0125
• 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: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2025

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: 09/28/2016
• Device Catalogue Number: 0115814
• Device Lot Number: HUVI0125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2011
• 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: Required Intervention; Disability
• Patient Age: 46 YR
• Patient Sex: Male