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

Catalog Number	0115810
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Hernia (2240); Disability (2371)
Date of Event	05/21/2012
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 "underwent an additional surgery to repair recurrent hernia after the kugel patch failed and to remove the kugel patch, which has entrapped the iliohypogastric and ilioinguinal nerves"; however, medical records were not provided.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.A review of the manufacturing records was performed and found that the lot was manufactured to specification.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) 2010: the patient underwent surgery for repair of a left inguinal hernia.As reported, the patient's hernia was repaired with a bard/davol modified kugel hernia patch, reference number 0115810, lot number huud0491.On (b)(6) 2012: the patient underwent an additional surgery to repair recurrent hernia after the kugel patch failed and to remove the kugel patch, which has entrapped the iliohypogastric and ilioinguinal nerves.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective kugel patch.
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 "underwent an additional surgery to repair recurrent hernia after the kugel patch failed and to remove the kugel patch, which has entrapped the iiiohypogastric and ilioinguinal nerves"; however, medical records were not provided.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.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct manufacturing date.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 1 years 8 months post implant of modified kugel patch, patient was diagnosed with nerve damage, inflammation, scar tissue and pain thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device list inflammation as a possible complication.Updated fields.(udi no),.Corrected field: h4 (manufacturing date) 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 or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2010: the patient underwent surgery for repair of a left inguinal hernia.As reported, the patient's hernia was repaired with a bard/davol modified kugel hernia patch, reference number 0115810, lot number huud0491.On (b)(6) 2012: the patient underwent an additional surgery to repair recurrent hernia after the kugel patch failed and to remove the kugel patch, which has entrapped the iliohypogastric and ilioinguinal nerves.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective kugel patch.Addendum per additional information provided: on (b)(6) 2010 - patient was diagnosed with left inguinal hernia thereby underwent open hernia repair with the implant of modified kugel hernia patch (device #1).Per operative notes, "the ilioinguinal nerve were dissected and protected.The hernia with large amount of preperitoneal fat protruded through internal ring was identified.All adherent adipose tissue in the cord was excised and the inguinal canal was cleared.A modified kugel patch was inserted in the inguinal floor and the piece of on lay mesh was anchored to the pubic tubercle medially.Laterally the mesh was split to accommodate the cord.The ends of mesh were secured with sutures." on (b)(6) 2012 - patient was diagnosed with entrapment of iliohypogastric nerve and ilioinguinal nerves in mesh thereby underwent explant of lateral portion of mesh, resection of entrapped iliohypogasatric and ilioinguinal nerves and implant of bard soft mesh (device #2).Per operative notes, "scar tissue noted at the pubic area, thickened area of mesh was noted superiorly to the area of pain, the mesh was dissected and a thick scar plate was noted with the mesh.The nerves associated with the mesh coming down.The iliohypogastric nerve and ilioinguinal nerves were noted and resected.The mesh lateral to the internal ring was resected.The remaining portion of mesh was anchored to the conjoint tendon with sutures.A bard soft mesh (device #2) was trimmed and placed to the lateral and sutured." on (b)(6) 2012 - patient was diagnosed with left inguinal hernia.Attorney alleged that the patient had adhesions, nerve damage, pain and emotional injuries.It was also alleged that the patient had excision of mesh and excision of entrapped nerves.

• 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: 7293339
• Report Number: 1213643-2018-00369
• Device Sequence Number: 19135630
• Product Code: FTL
• UDI-Device Identifier: 00801741030796
• UDI-Public: (01)00801741030796(17)150428(10)HUUD0491
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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: 04/28/2015
• Device Catalogue Number: 0115810
• Device Lot Number: HUUD0491
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2010
• 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: 38 YR
• Patient Sex: Male
• Patient Weight: 80 KG