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

Catalog Number	0115808
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Hernia (2240); Disability (2371)
Date of Event	01/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided we are unable to determine to what extent, if any the bard device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges that the patient "was found to have recurrent hernias with incarceration." medical records are not available at this time, however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.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.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) 2008: the patient underwent open procedure for an inguinal hernia.As reported, the patient's hernia was repaired with a bard/davol 7.6cm oval {modified} kugel patch, product code 0115808.On (b)(6) 2016: the patient presented to the hospital with complaints of severe pain and was found to have recurrent hernias with incarceration.On (b)(6) 2016: the patient underwent a laparoscopic bilateral hernia repair and reduction of incarcerated hernia.As reported, his recurrent hernias were repaired with a bard/davol 3dmax and bard/davol ventralex mesh.As alleged, the patient was seriously and permanently injured and has suffered and will continue to suffer physical pain due to the alleged defective kugel patch.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2008: the patient underwent open procedure for an inguinal hernia.As reported, the patient's hernia was repaired with a bard/davol 7.6cm oval {modified} kugel patch, product code 0115808.(b)(6) 2016: the patient presented to the hospital with complaints of severe pain and was found to have recurrent hernias with incarceration.(b)(6) 2016: the patient underwent a laparoscopic bilateral hernia repair and reduction of incarcerated hernia.As reported, his recurrent hernias were repaired with a bard/davol 3dmax and bard/davol ventralex mesh.As alleged, the patient was seriously and permanently injured and has suffered and will continue to suffer physical pain due to the alleged defective kugel patch.Addendum per additional information provided: (b)(6) 2008 - patient was diagnosed with left inguinal hernia thereby underwent open repair with the implant of modified kugel hernia patch (device #1).Per operative notes, ¿patient was found to have a large defect of the floor with a very large direct hernia.The floor was opened and the preperitoneal tissue was mobilized circumferentially.A modified kugel patch (device #1) was placed on the floor.The accompanying ribbons were sewn, one to the transversalis fascia and other to inguinal ligament.The floor was then closed over the patch.¿ (b)(6) 2016 - patient was diagnosed with bilateral inguinal hernias with indirect left inguinal hernia, direct right inguinal hernia, right upper quadrant probable incisional hernia with incarceration thereby underwent laparoscopic repair with implant of two 3dmax meshes (device #2 - right, device#3 - left) and ventralex st (device #4).Per operative notes, ¿there was left inguinal hernia and a direct right inguinal hernia.Patient had significant scarring but also able to reduce the indirect hernia sac.A 3dmax mesh (right - device #2) and 3dmax (left - device #3) was placed and tacked.There was some overlap of the mesh.The peritoneum was then brought up and over to completely cover the mesh.For upper abdominal hernia, a small ventralex st mesh (device #4) was placed and sutured.¿ (note: there is no mention/visualization of modified kugel patch (device #1) in operative notes).Attorney alleges that the patient had pain, hernia recurrence and emotional injuries.Also, the attending physicians found 2 other herniated areas during the mesh surgery.
Additional Manufacturer Narrative
Based on the information provided we are unable to determine to what extent, if any the bard device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges that the patient "was found to have recurrent hernias with incarceration." medical records are not available at this time, however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.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.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 7 years 7 months post implant of modified kugel patch, patient was diagnosed with hernia recurrence and scar tissue thereby underwent additional surgery.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Updated fields: a2, a4, b4, b5, b7, d4 (corporate lot no) (expiry date), e3, g1, g3, g6, h2, h4, h6, h10 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.

• 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: 7268443
• Report Number: 1213643-2018-00276
• Device Sequence Number: 1475226
• Product Code: FTL
• UDI-Device Identifier: 00801741030789
• UDI-Public: (01)00801741030789
• 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: 2008
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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: 04/28/2013
• Device Catalogue Number: 0115808
• Device Lot Number: HUSC0348
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2008
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 91 KG