MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 KUGEL PATCH; SURGICAL MESH

Catalog Number	0010105
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Pain (1994); Hernia (2240); Injury (2348); Disability (2371); Drug Resistant Bacterial Infection (4553)
Date of Event	05/29/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges surgical intervention and "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol kugel patch (device #2).Additional emdrs were submitted to represent the bard/davol mesh ¿ composix kugel (device #1) and bard/davol kugel patch (device #3).Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix kugel hernia patch on (b)(6) 2003 and two kugel hernia patches on (b)(6) 2003 and (b)(6) 2004.As reported, the patient is making a claim for an adverse patient outcome against all devices.It is alleged that the patient had revision surgery on (b)(6) 2011.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix kugel hernia patch on (b)(6) 2003 and two kugel hernia patches on (b)(6) 2003 and (b)(6) 2004.As reported, the patient is making a claim for an adverse patient outcome against all devices.It is alleged that the patient had revision surgery on (b)(6) 2011.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 1992 ¿ patient ventral hernia thereby underwent repair with the implant of bard flat mesh (device 1).(note: there is no op notes provided for this procedure in medical records) (b)(6) 1995 ¿ patient had ventral hernia thereby underwent repair with the implant of bard flat mesh (device 2).(note: note: there is no op notes provided for this procedure in medical records) (b)(6) 2003 ¿ patient had recurrent ventral hernia thereby underwent repair with the implant of composix kugel mesh (device 3) and kugel patch (device 4).(note: there is no op notes provided for this procedure in medical records).(b)(6) 2004 ¿ patient had recurrent ventral hernia thereby underwent implant of kugel patch (device 5).Note: there is no op notes provided for this procedure in medical records).(b)(6) 2011 ¿ patient was diagnosed with abdominal abscess thereby underwent incisional and drainage of abscess.Per op notes, ¿the abscess was drained.The entire base was consisted of an apparent gore-tex (device 3) mesh graft.¿ (b)(6) 2011 - patient was diagnosed with infected abdominal wall mesh and abscess thereby underwent open repair with partial removal of gore-tex mesh (device 3).Per op notes, ¿there was a minimal residual purulent drainage.The periphery of mesh was fibrosed and not sheathed.There were recurrent hernias on periphery of mesh was removed leaving central portion of mesh.¿ (b)(6) 2012 ¿ patient was diagnosed with infected mesh and multiple abdominal hernias thereby underwent open repair with the removal of mesh (device 3).Per op notes, ¿a partially incarcerated hernia was noted.The sinus tract had been draining in area of infected mesh.A small portion of gore-tex mesh was removed.¿ (b)(6) 2013 ¿ patient was diagnosed with multiply recurrent incisional hernia, infected mesh thereby underwent open repair with the removal of meshes (device 1, 2, 4, 5).Per op notes, ¿fistulous tract connected to infected mesh was dissected down.Adhesiolysis was done.Four different types of mesh, each sorted patched on to one another with both continuous sutures.Some of the mesh was divided.The meshes were removed.A onlay patch of synthetic mesh was placed into pubis and sutured.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges surgical intervention and "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct date of event.Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.This supplemental emdr represents the kugel patch (device 4).An additional supplemental emdr was submitted to represent the bard/davol composix kugel mesh (device 3) and kugel patch (device 5).The additional mdrs were submitted to represent the bard flat mesh (device 1 and device 2).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.

• Brand Name: KUGEL PATCH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: 10086408
• Report Number: 1213643-2020-05099
• Device Sequence Number: 11372145
• Product Code: FTL
• UDI-Device Identifier: 00801741016370
• UDI-Public: (01)00801741016370(10)43HND294
• 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: 2003
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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 Catalogue Number: 0010105
• Device Lot Number: 43HND294
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 103 KG