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

Model Number	0115808
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pain (1994); Disability (2371)
Date of Event	06/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.With the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Not returned to manufacturer.
Event or Problem Description
The following was reported to davol by the patient's attorney: on (b)(6) 2012 - the patient underwent a left inguinal herniorrhaphy for a left inguinal hernia.The patient's hernia was repaired with a small circle modified kugel patch.On (b)(6) 2017 - the patient underwent an additional surgery to remove the previously placed kugel mesh.The attorney alleges the patient has suffered and will continue to suffer physical pain and was injured severely and permanently.
Event or Problem Description
The following was reported to davol by the patient's attorney: (b)(6) 2012 - the patient underwent a left inguinal herniorrhaphy for a left inguinal hernia.The patient's hernia was repaired with a small circle modified kugel patch.(b)(6) 2017 - the patient underwent an additional surgery to remove the previously placed kugel mesh.The attorney alleges the patient has suffered and will continue to suffer physical pain and was injured severely and permanently.Addendum per additional information received: (b)(6) 2012 - patient was diagnosed with left indirect inguinal hernia and underwent repair with modified kugel hernia patch.Per op notes ¿the round ligament was identified.We found a indirect hernia sac.We used a 3.0 modified kugel hernia patch and placed in the preperitoneal space.The onlay mesh was then placed on the floor of the inguinal canal and tacked in place." (b)(6) 2017 - patient developed with abdominal pain, underwent total abdominal hysterectomy, bilateral salpingectomy and left anterolateral peritoneal surgical mesh partial transection.Per the operative notes," in order to minimize risk of recurrent inflammatory intra-abdominal reaction to the mesh presumably used in the left inguinal hernia repair.This was incised and sent to pathology.The peritoneum was reapproximated over the edge in order to reduce risk of contact with intra-abdominal organs with the edge of the mesh.¿ attorney alleges mesh migration, emotional injuries, infections and depression.
Additional Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.With the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum: this supplemental mdr is submitted to document additional information provided.Based on the information provided, no conclusion can be made.Per medical records provided, about 4 years post implant of modified kugel hernia patch, patient developed with abdominal pain and underwent additional surgery for partial excision of the mesh.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: 6981658
• Report Number: 1213643-2017-00725
• Device Sequence Number: 19188339
• 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: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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: 06/28/2017
• Device Model Number: 0115808
• Device Catalogue Number: 0115808
• Device Lot Number: HUWE0978
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2012
• 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; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 60 KG