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

Model Number 0115810

Device Problems Hole In Material (1293); Defective Device (2588); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Internal Organ Perforation (1987); Pain (1994); Disability (2371)

Event Date 09/09/2006

Event Type  Injury  

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.The information provided indicates the patient experienced pain, swelling, abscess and adhesions.In regards to adhesions, adhesions are listed as a known possible adverse reaction in the instructions-for-use.The information also indicated that the mesh had a "hole" in it.A sample was not returned for evaluation therefore the allegation of a "hole" in the mesh can not be confirmed.The modified kugel is designed in such a way that there is an opening in the dual mesh.It is unclear if this designed opening is what is being referred to when talking about the hole in the mesh.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 Description

The following was reported to davol by the patient's attorney: on (b)(6) 2006 - the patient underwent an open abdominal surgery for a ventral incisional hernia.The patient's hernia was repaired with a four inch modified kugel patch.On (b)(6) 2006 - the patient presented to the er with complaints of pain, swelling and redness of lower abdomen.The patient was allegedly found to have "an abscess." the patient underwent an incision and drainage of the abscess in her lower abdominal wall.On (b)(6) 2015 - the patient underwent surgery to have laparoscopic repair of an incarcerated ventral hernia.The attending surgeon stated "severe adherence of bladder to old mesh and had a hole in it." the patient was sent to recovery and discharged two days later.The attorney alleges the patient experienced adhesions, swelling, abscess and was seriously and permanently injured.

Manufacturer Narrative

Addendum to the initial report.This supplemental emdr is being sent to update outcomes attributed to adv ev and the device code + description.With the current information available no conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.

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.The information provided indicates the patient experienced pain, swelling, abscess and adhesions.In regards to adhesions, adhesions are listed as a known possible adverse reaction in the instructions-for-use.The information also indicated that the mesh had a "hole" in it.A sample was not returned for evaluation therefore the allegation of a "hole" in the mesh can not be confirmed.The modified kugel is designed in such a way that there is an opening in the dual mesh.It is unclear if this designed opening is what is being referred to when talking about the hole in the mesh.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 #1: addendum to the initial report.This supplemental emdr is being sent to update outcomes attributed to adv ev (sec.B2) and the device code + description (sec.F10).With the current information available no conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.Addendum #2: h11: this supplemental mdr is submitted to document additional information provided and to correct the manufacturing date.Based on the information provided, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.Adhesions and infection are known inherent risks of surgery/use of the device.Regarding infection, the warning section of the instructions-for-use supplied with the device states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.Unresolved infection may require removal of the device." not returned.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2006 - the patient underwent an open abdominal surgery for a ventral incisional hernia.The patient's hernia was repaired with a four inch modified kugel patch.(b)(6) 2006 - the patient presented to the er with complaints of pain, swelling and redness of lower abdomen.The patient was allegedly found to have "an abscess." the patient underwent an incision and drainage of the abscess in her lower abdominal wall.(b)(6) 2015 - the patient underwent surgery to have laparoscopic repair of an incarcerated ventral hernia.The attending surgeon stated "severe adherence of bladder to old mesh and had a hole in it." the patient was sent to recovery and discharged two days later.The attorney alleges the patient experienced adhesions, swelling, abscess and was seriously and permanently injured.Addendum per additional information provided.(b)(6) 2006 - the patient was diagnosed with reducible ventral incisional hernia and underwent open repair with the implant of modified kugel mesh.Per the operative notes," the hernia sac was sharply dissected out from the defect.A kugel mesh patch (modified kugel mesh) measuring 4 inch in diameter was taken and was sutured continuously.A j-vac drain was placed." (b)(6) 2006 - the patient was developed with right-sided abdominal area tenderness and there is some purulent drainage noted from the drain site with redness along that right lower abdominal wall area around the area of the drain site suggesting abdominal wall cellulitis and possible wound infection and was treated with medication avelox.(b)(6) 2006 - the patient developed swelling, tenderness in abdominal wall and was diagnosed with cellulitis and abscess of the abdominal wall and admitted in the hospital.(b)(6) 2006 - the patient underwent incision and drainage of abscess lower abdominal wall.Per the operative notes, "the abscess cavity was entered.Abscess cavity was drained of all the purulent material, which was sent for culture.The wound was thoroughly irrigated, and the wound was packed with iodoform packing.¿ (b)(6) 2006 - the patient visited hospital for follow-up and was developed with candida vaginitis and having some loose stools.The patient was advised to continue nafcillin medication until (b)(6) 2006.(b)(6) 2015 - the patient was diagnosed with incarcerated incisional ventral hernia (note, this appears to be a new hernia) and underwent laparoscopic repair with mesh implant.Per operative notes after repairing new hernia, "while exploring the pelvis, it was noted that the bladder was located in the left lower quadrant, severely displaced, and adhered significantly to the previously placed mesh (modified kugel) from prior surgery.While freeing adhesions from that mesh it had been iatrogenically entered.Once it was identified, it was inspected, and it was noted that there was a small hole in the bladder.This was primarily closed.¿.

• Brand Name: MODIFIED KUGEL PATCH
• Type of Device: 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: 6942336
• MDR Text Key: 89245209
• Report Number: 1213643-2017-00667
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030796
• UDI-Public: (01)00801741030796
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2011
• Device Model Number: 0115810
• Device Catalogue Number: 0115810
• Device Lot Number: 43AQD821
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 61 KG