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

Model Number	0115810
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Cellulitis (1768); Pain (1994); Seroma (2069); Hernia (2240); Disability (2371)
Date of Event	12/01/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently, it is unknown whether the device may have caused or contributed to the reported event.To date no medical records have been provided.The information provided alleges the patient experienced hernia recurrence, recurrence is listed as a known possible adverse reaction in the instructions-for-use.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.
Event or Problem Description
The following was reported to davol by the patient's attorney: (b)(6)2010 - the patient underwent surgery for repair of an inguinal hernia, the patient's hernia was repaired with a modified kugel patch.(b)(6) 2011 - the patient underwent an additional surgery to remove the previously placed modified kugel mesh, which failed, and repair recurrent inguinal hernia.The attorney alleges the patient experienced pain, doctor visits, subsequent procedures and was injured severely and permanently.
Additional Manufacturer Narrative
This is an addendum to the initial mdr to correct the manufacture date and expiration date.Section a through f - 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.
Event or Problem Description
The following was reported to davol by the patient's attorney: (b)(6) 2010 - the patient underwent surgery for repair of an inguinal hernia, the patient's hernia was repaired with a modified kugel patch.(b)(6) 2011 - the patient underwent an additional surgery to remove the previously placed modified kugel mesh, which failed, and repair recurrent inguinal hernia.The attorney alleges the patient experienced pain, doctor visits, subsequent procedures and was injured severely and permanently.Addendum per additional information provided: (b)(6) 2010 - patient was diagnosed with right scrotal hernia and underwent open repair with modified kugel patch (device #1).Per the operative report details, "the massive hernia sac was retracted and reduced.The testicle was placed back in proper position and a large, modified kugel patch was placed and sutured".(b)(6) 2010 - patient was diagnosed with left inguinal hernia and underwent repair with modified kugel patch (device #2).Per the operative notes, "the direct space hernia was noted and a modified kugel patch was placed and sutured".(b)(6) 2011 - patient developed right groin pain, recurrent right inguinal hernia and underwent open repair with synthetic mesh and removal of previous mesh (device #1).Per the operative notes, a very large direct inguinal hernia was identified.The hernia mesh had separated from the floor, folded around the inguinal cord contents and had a few adhesions to the floor, which were divided sharply.The mesh was separated and a small portion of the mesh was left at the other side of the hernia sac.A synthetic mesh was placed to repair the defect." (b)(6) 2011 - patient was diagnosed with large complex right groin abscess, cellulitis, seroma and underwent incision and drainage.Per the operative notes, "dark brown serous fluid drained from incision site.There are some necrotic subcutaneous tissue and infected old hematoma was removed from the right groin.The mesh in the right groin was not visualized and no evidence of exposed mesh." attorney alleges that the patient had abscess, adhesions, emotional injuries without treatment, infection, nerve damage, pain and recurrence.
Additional Manufacturer Narrative
Currently, it is unknown whether the device may have caused or contributed to the reported event.To date no medical records have been provided.The information provided alleges the patient experienced hernia recurrence, recurrence is listed as a known possible adverse reaction in the instructions-for-use.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum #1: this is an addendum to the initial mdr to correct the manufacture date and expiration date.Addendum #2: this supplemental mdr is submitted to document additional information provided and to correct manufacturing date.Based on the available information, no conclusion can be made.Per medical record provided, over a year post implant of modified kugel patch, patient developed abdominal pain, hernia recurrence, abscess, adhesions, cellulitis, seroma and underwent mesh explant.Per medical record provided, "the hernia mesh had separated from the floor, folded around the inguinal cord contents" seroma and adhesions are known inherent risk of surgery and listed in the adverse reactions section of the instructions-for-use, supplied with the device, as possible complication.Review of manufacturing records confirms product was manufactured to specification.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: 7007213
• Report Number: 1213643-2017-00794
• Device Sequence Number: 1601366
• Product Code: FTL
• UDI-Device Identifier: 00801741030796
• UDI-Public: (01)00801741030796
• 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: 2010
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2023

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: 11/28/2014
• Device Model Number: 0115810
• Device Catalogue Number: 0115810
• Device Lot Number: HUTJ1123
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 04/26/2018; 06/08/2023
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 05/04/2018; 07/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2009
• 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; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 122 KG