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

Catalog Number	0010103
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Pain (1994); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	09/03/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.No lot number has been provided therefore a review of the manufacturing records is not possible.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that on (b)(6) 2009, the patient underwent surgery for implant of an unspecified bard/davol modified kugel hernia patch.As reported, the patient is making a claim for an adverse patient outcome against the modified kugel hernia patch.As reported, the 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.".
Event or Problem Description
Attorney alleges that on (b)(6) 2009, the patient underwent surgery for implant of an unspecified bard/davol modified kugel hernia patch.As reported, the patient is making a claim for an adverse patient outcome against the modified kugel hernia patch.As reported, the 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." addendum per additional information provided: (b)(6) 2009 ¿ patient was diagnosed with ventral hernia thereby underwent open repair with the implant of kugel patch.Per op notes, ¿the hernia sac was completely excised.A small circle of kugel patch underneath the fascia and sutured.¿ (b)(6) 2013 - patient had abdominal pain and was diagnosed with small bowel obstruction thereby underwent laparoscopic repair with the removal of kugel patch.Per op notes, ¿dense adhesions of small intestine to mesh itself were taken down.The mesh appeared to be rolled up in several areas and was the point of obstruction.The mesh was removed.¿ (b)(6) 2013 ¿ patient had pelvis abscess thereby underwent ct guided abscess drainage.(b)(6) 2014 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of unknown mesh.Per op notes, ¿adhesion was taken down.A piece of mesh was placed at the center of the defect using sutures.¿ (note: the mesh implanted during this procedure was unknown).
Additional Manufacturer Narrative
At this time no conclusions can be made.No lot number has been provided therefore a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.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.Note, the manufacturing date (15-sep-2008) is considered to be a best estimate.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: MODIFIED 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: 8899459
• Report Number: 1213643-2019-07210
• Device Sequence Number: 16551195
• Product Code: FTL
• UDI-Device Identifier: 00801741016356
• UDI-Public: (01)00801741016356(17)131028(10)HUSI0394
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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 Expiration Date: 10/28/2013
• Device Catalogue Number: 0010103
• Device Lot Number: HUSI0394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2008
• 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: 44 YR
• Patient Sex: Male