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

Catalog Number UNKAA043

Device Problems Device Appears to Trigger Rejection (1524); Defective Device (2588); Extrusion (2934); Material Protrusion/Extrusion (2979); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Erosion (1750); Fistula (1862); Unspecified Infection (1930); Pain (1994); Hernia (2240); Disability (2371); Impaired Healing (2378)

Event Date 01/05/2016

Event Type  Death  

Manufacturer Narrative

Based on the information provided, we are unable to determine to what extent, if any the bard kugel patch (device #2) may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges the patient "was found to have infected and extruding mesh".The sample was not returned for evaluation and medical records are not available at this time.Adhesions are 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.Regarding infection the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ 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.This emdr represents the bard device implanted on (b)(6) 2013 (device #2).An additional emdr was submitted to represent the bard device implanted on (b)(6) 2007 (device #1).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.Device not returned.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2007: the patient underwent a ventral hernia repair with mesh that, "upon information and belief, was manufactured by bard." (device #1).(b)(6) 2013: the patient underwent an incisional surgery for a recurrent ventral hernia.The patient's hernia was repair with a bard/davol large oval kugel patch (device #2).(b)(6) 2016: the patient presented to the doctor with complaints of severe pain and extrusion of mesh.As reported, he was found to have infected and extruding mesh.(b)(6) 2016: the patient underwent surgery on the infected mesh.As reported, an exploratory laparotomy, lysis of adhesions, small bowel resection with primary anastomosis, and debridement of his abdominal wall soft tissue were performed and he was sent to the recovery room in stable condition.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 Description

The following was alleged by the patient's attorney: (b)(6) 2007: the patient underwent a ventral hernia repair with mesh that, "upon information and belief, was manufactured by bard." (device #1) (b)(6) 2013: the patient underwent an incisional surgery for a recurrent ventral hernia.The patient's hernia was repair with a bard/davol large oval kugel patch (device #2).(b)(6) 2016: the patient presented to the doctor with complaints of severe pain and extrusion of mesh.As reported, he was found to have infected and extruding mesh.(b)(6) 2016: the patient underwent surgery on the infected mesh.As reported, an exploratory laparotomy, lysis of adhesions, small bowel resection with primary anastomosis, and debridement of his abdominal wall soft tissue were performed and he was sent to the recovery room in stable condition.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 legal claim: attorney alleges that the patient underwent surgery for the implant of an unspecified bard/davol kugel hernia patch on (b)(6) 2013.As reported, the plaintiff is making a claim for an adverse patient outcome against the kugel hernia patch.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device and wrongful death of the patient.The attorney stated that the patient was passed away on (b)(6) 2021 due to defendant's negligence, defective product and defective design.It is also alleged that the plaintiff experienced emotional distress, sustained severe emotional pain, suffering and the device was defective.

Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any the bard kugel patch (device #2) may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges the patient "was found to have infected and extruding mesh".The sample was not returned for evaluation and medical records are not available at this time.Adhesions are 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.Regarding infection the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ 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.This emdr represents the bard device implanted on 02/14/2013 (device #2).An additional emdr was submitted to represent the bard device implanted on 06/15/2007 (device #1).Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental emdr is submitted to report the additional event information provided.No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including death.No medical records, autopsy report, or death certificate have been provided.Corrected fields: b3 (event date).The adverse reactions section of the instructions-for-use (ifu) supplied with the device lists adhesions, extrusion, recurrence of the hernia as possible complications.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.

Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any the bard kugel patch (device #2) may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges the patient "was found to have infected and extruding mesh".The sample was not returned for evaluation and medical records are not available at this time.Adhesions are 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.Regarding infection the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ no lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Addendum #1 h11: this is an addendum to the initial mdr submitted.This supplemental emdr is submitted to report the additional event information provided.No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including death.No medical records, autopsy report, or death certificate have been provided.The adverse reactions section of the instructions-for-use (ifu) supplied with the device lists adhesions, extrusion, recurrence of the hernia as possible complications.Addendum #2: h11: this supplemental emdr is submitted to document additional information provided and to correct date of event, mdr classification and type of reportable event.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.There was no autopsy report, death certificate or other information related to the patient death, included in the medical records provided.As such the cause of death is unknown.Per medical records review, about 2 years 10 months post implant of kugel patch, patient was diagnosed with infection, chronic non healing wound, adhesions, erosion, protrusion/extrusion of mesh, fistula thereby underwent repair with mesh removal.Per op notes, ¿patient had obvious extrusion of infected mesh" and "patient had mesh protruding from the umbilicus and chronic non healing wound." the instructions-for-use supplied with the device list fistula as a possible complication.This supplemental emdr represents the kugel patch (device #2).An additional supplemental emdr was submitted to represent bard flat mesh (device #1).

Event Description

The following was alleged by the patient's attorney: (b)(6) 2007: the patient underwent a ventral hernia repair with mesh that, "upon information and belief, was manufactured by bard." (device #1).(b)(6) 2013: the patient underwent an incisional surgery for a recurrent ventral hernia.The patient's hernia was repair with a bard/davol large oval kugel patch (device #2).(b)(6) 2016: the patient presented to the doctor with complaints of severe pain and extrusion of mesh.As reported, he was found to have infected and extruding mesh.(b)(6) 2016: the patient underwent surgery on the infected mesh.As reported, an exploratory laparotomy, lysis of adhesions, small bowel resection with primary anastomosis, and debridement of his abdominal wall soft tissue were performed and he was sent to the recovery room in stable condition.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 legal claim: attorney alleges that the patient underwent surgery for the implant of an unspecified bard/davol kugel hernia patch on (b)(6) 2013.As reported, the plaintiff is making a claim for an adverse patient outcome against the kugel hernia patch.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device and wrongful death of the patient.The attorney stated that the patient was passed away on (b)(6) 2021 due to defendant's negligence, defective product and defective design.It is also alleged that the plaintiff experienced emotional distress, sustained severe emotional pain, suffering and the device was defective.Addendum per additional information provided: (b)(6) 2013 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of kugel hernia patch (device #2).Per operative notes, ¿the old scar was removed.Patient was found to have multiple hernia defects.The ventral hernia was reduced, and multiple adhesions were taken down.A kugel patch (device #2) was placed intraperitoneally.¿ (b)(6) 2016 - patient had mesh protruding from the umbilicus and chronic non healing wound.A large portion of mesh (device #2) was removed at bedside.Patient will require surgical intervention to completely explant remaining mesh.(b)(6) 2016 - patient was diagnosed with history of infected mesh, suspected mesh enterocutaneous fistula thereby underwent lysis of adhesions and repair with removal of mesh (device #2).Per operative notes, ¿patient had obvious extrusion of infected mesh, erosion of mesh through the skin and a chronic draining wound.A segment of the mesh fistulized to an area of the small bowel.The segment of small bowel and mesh removed (device #2).¿ note: there is no mention/visualization of bard mesh (device #1) (that bd field assurance considered may have been implanted on 2007) in the medical records and plaintiff profile form provided.Attorney alleges that the patient had adhesions, bowel/intestinal removals, fistulae, infections, pain, hernia recurrence.It was also alleged that patient had erosion and protrusion of mesh through the skin, resection of small bowel which had a portion of mesh fistulized to it, chronic draining wound and debridement of abdominal wall.

• Brand Name: 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: 7221462
• MDR Text Key: 98348173
• Report Number: 1213643-2018-00133
• Device Sequence Number: 1
• Product Code: FTL
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA043
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Disability; Required Intervention; Death
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 92 KG