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

Catalog Number	0010102
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994); Hernia (2240); Disability (2371); Fibrosis (3167)
Date of Event	11/02/2011
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 presented with "complaints of chronic pain, recurrent hernia and infected mesh" and underwent surgical procedure to "remove the infected mesh and repair the recurrent ventral hernia" however medical records are not available at this time.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.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.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) 2009: the patient underwent a ventral hernia repair with mesh.As reported, the patient's hernia was repair with a bard davol 14 x 17 oval kugel patch, product code no.0010102.On (b)(6) 2011: the patient presented to the hospital with complaints of chronic abdominal pain, recurrent hernia and infected mesh and underwent a surgical procedure to remove the infected mesh and repair the recurrent ventral hernia.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.
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 presented with "complaints of chronic pain, recurrent hernia and infected mesh" and underwent surgical procedure to "remove the infected mesh and repair the recurrent ventral hernia" however medical records are not available at this time.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.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: 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 2 years 5 months post implant of kugel patch, patient was diagnosed with purulent discharge, bacterial infection, fibrosis, adhesions and pain thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists adhesion as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.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.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2009: the patient underwent a ventral hernia repair with mesh.As reported, the patient's hernia was repair with a bard davol 14 x 17 oval kugel patch, product code no.0010102.(b)(6) 2011: the patient presented to the hospital with complaints of chronic abdominal pain, recurrent hernia and infected mesh and underwent a surgical procedure to remove the infected mesh and repair the recurrent ventral hernia.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 medical records provided: (b)(6) 2009 - patient was diagnosed with ventral incisional hernia thereby underwent open repair with the implant of kugel patch.Per operative notes, ¿once the fascia was encountered, there were multiple defects.The fascia was incised and peritoneal adhesions were dissected away from the anterior abdominal wall.An oval kugel patch was placed into the wound between the posterior rectus sheath and the rectus muscle, tacked in place peripherally using sutures incorporating the ring of the mesh.¿ (b)(6) 2011 - patient was diagnosed with chronic abdominal draining sinus, infected mesh and pain thereby underwent removal of kugel patch and ventral hernia defect repair.Per operative notes, ¿scar tissue from previous repair was excised and sinus was then amputated.It was evident that the mesh itself was infected.There was some purulent type of discharge coming from this sinus opening.The mesh was split open in the midline, it appeared the mesh was placed in retro rectus fashion and the mesh was excised in its entirety.There were some small bowel interloop adhesions which were lysed.Due to the previous mesh being infected, a biological mesh was placed to the close this large ventral hernia defect at the anterior and posterior rectus sheaths.¿ attorney alleges that the patient had infection, pain, chronic wound infections, drainage and emotional injuries.

• Brand Name: 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: 7245936
• Report Number: 1213643-2018-00213
• Device Sequence Number: 10804312
• Product Code: FTL
• UDI-Device Identifier: 00801741016349
• UDI-Public: (01)00801741016349(17)130128(10)HUSA0837
• 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: 2009
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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: 01/28/2013
• Device Catalogue Number: 0010102
• Device Lot Number: HUSA0837
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2008
• 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: 38 YR
• Patient Sex: Female